August 2017 li Volume 101 li Number 8S-1 lantation KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors @ wolters KluwerTP_V101NS_EB ransplantation Editor-in-Chief Jeremy R. Chapman Executive Editors carla c. Baan Edward K. Geissler Elizabeth A. Pomfret Jonathan §. Bromberg Stofan G. Tullius Deputy Editors Ignacio Anogon ‘Anita 8. Chong Kwan Man Marina Berenguer Jean ¢. Emond Kazunari Tanabe Daniel C. Brennan Christophe Legendre Holio Tedesco Silva, Jr Managing Editor Social Media Edito Editorial Fell Gillian Hughos Frank J.M.F. Dor Joo! Thomas Adlor Karen Keung, Editorial Coordinate Editorial Assistants eri Kocabayeglu ‘Sarah Francom cathy MeMitian ‘andrea Schlegel Daralynn Pilkie Associate Editor Stephen I. Alexander Martin J. Hoogdulin Suetonia Palmer Hatem Amor Kirsten Howard ‘Stovon Paraskovas Dany Anglicheau ‘Atul Humar Alchard N. Plorson, I Thierry Berney Jamos Hutchinson Emilio Poggio, Oriol Bestard Suzanne lldstad acu poo rooz Broumand Fad ssa Monaroad ie ‘George Burke, Ill Ina Jochmans EDomunl Reneer Marcelo Cantarovich Michelle J. Josephson pester Fe ‘Stove Chadban Kathryn Kable ecinecnieene ‘See Ching Chan ‘Tomoakl Kato Z Michael R. Chariton Christina Kautman Mylene Sebagh Pater Chin-Hong Camille Nelson Kotton ‘A.M. James Shapiro Frans Claas Deepali Kumar Nina Singh Philip Clayton Dirk Kuypers Bonu sis Emanuele Cozzi Choon Hyuck David Kwon Jon Snydor Ellas David-Noto Danlola P. Ladnor Laurie Snyetor Mary Amanda Dew Titte Srinivas Geraldine C. Diaz Poter Stock Frank JM.F. Dor ‘Simone I. Strasser srapnan Ensminger iota Loupy veCaner Sueal shan Er odie, a Stovon Gabardl Olivia M. Martinez Tkcsen Teaa ‘Tom Gallagher Valeria Mas. anges neneen ‘Jens Goebel allan Massie Gabriel E. Gondoles! David Mathes lligon Tong Plerre-Antoine Gourraud ‘Neelam Mohan Bee ene ‘Shane T. Grey imi Muller Geert Verteden Carole Gulilonnesu Marton Naosens Gregor Warnecke ‘Susan Gunderson David Neujahr Germaine Wong sundaram Hariharan Claus Niemann Helal Yeh Raymond L. Heilman Douglas Norman Luis G, Hidalgo ‘Yuan Zhal Giuseppe Orlando Emmanuel Zorn Editor's Advisory J. Andrew Bradley Anthony P. Monaco David H. Sachs Leslie Brent Peter J. Morris ‘Manikkam Suthanthiran Franels L. Dalmonleo James Neuberger Mark A. Hardy Kathryn J. Wood Philip J. 0'Connelt‘TP_V101N8_ST_TEXT Transplantation’ ~ Contents ae . Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group s2 oe : Methods for Guideline Development s13 Chapter 2: Informed Consent s8 ‘Chapter 3: Compatibility Testing, Incompatible Transplantation, and Paired Donation .... so Chapter 8: Kidney Stones .. " $10 Chapter 9: Hyperuricemia, Gout, and Mineral and Bone Disease $10 Chapter 11: Predonation Metabolic and Lifestyle Risk Factors s10 Chapter 12: Preventing Infection Transmission sit Chapter 18: Ethical, Legal and Policy Considerations $13 Appendix: Biographic and Disclosure Information...... $106TP_V101N8_ST_TABLE Transplantation Contents Table 1. Key questions defining the evidence review Table 2. Systematic review screening criteria Table 3. Evidence quality assessment criteria Table 4. KDIGO nomenclature and description for grading recommendations Table 5. Determinants of strength of a recommendation Table 6. Final grade for overall quality of evidence . Table 7. Reasons wty many ungraded recommendations are iesuod inthis guideline _ ni vo ‘Table 8. The Conference on Guideline Standardization (COGS) checklist for reporting clinical practice guidelines... . Table 9. Approaches to implementation of a quantitative framework for donor candidate medical evaluation and acceptance centered on lifetime risk of kidney failure Table 10. Roles and responsibilities of participants in donor candidate identification, evaluation, care, and follow-up .. a ‘Table 11. Recommended content of disclosure during the evaluation of living donor candidates a Table 12. Sources of error in GFR estimation using creatinine ... Table 13. Sources of error in GFR estimation using cystatin Table 14, Factors affecting urinary ACR Table 18. Relationship among categories for albuminuria and proteinuria Table 16. US Public Health Service (PHS) 2013 Screening for factors associated with increased likelihood of recent HIV, HBV or HCV infection Table 17. Microbiological screening to reduce the risk of living donor-derived infection transmission ‘Table 18. Social and clinical factors associated with increased likelihood of geographically endemic infections and infections related to specific exposures a sis Table 19, Recognized organ donor-derived infection transmissions ‘Table 20. Bosniak renal cyst classification system....... Table 21. International TNM staging system for renal cell carcinoma ‘Table 22. Donor characteristics and matemal and fetal outcomes in postdonati regnancios from three studios: Norway, Minnesota (United States) and Ontario (Canada) . son Table 23. Recommended processes and content of the psychosocial evaluation ‘Table 24. Recommendations for psychosocial factors that either exclude donation, or prevent further evaluation until resolution s14 S15 si7 sia s19 s19 s20 s21 ses seo s70 s73 874 sso sat se2‘TP_V101N8_ST_FIGURES I | t ti rt Contents Figure 1. Perspectives of risk in living kidney donation S16 Figure 2. Literature flow diagram si7 Figure 3, Framework to accept or decline donor candidates based on a transplant program's threshold of acceptable postdonation risk. s23 Figure 4. Framework to accept or decline donor candidates based on a transplant program's threshold of acceptable projected lifetime risk of kidney failure, quantified as the aggregate of risk related to cemeoort and health profile and donation-attributable risks...... - S24 Figuro 5. Performance of the CKD-EPI equation in estimating measured GFR s37 Figure 6. Complications of CKD according to baseline eGFR and albuminuria... 539 Figure 7. Estimated 15-yr incidence (4) of ESKD in the United States according to baseline eGFR and demographic profile from the CKD-PC. s40 Figure 8. Estimated lifetime incidence (%) of ESKD in the United States according to baseline eGFR and demographic profile from the CKD-PG sat Figure 9. Estimated 15-yr incidence (%) of ESKD in the United States according to basetne alsumin-to-creatinine ratio (ACR, mals) and demographic profile from the CKD-PC.. Figure 10, Estimated ittime incidence (%) of ESKD inthe United States according to baseline albumin-to-creatinine ratio (ACR, mg/g) and demographic profile S45 from the CKD-PC. sas Figure 11. Proteinuria after kidney donation sae Figure 12. Meta-analysis of proteinuria after kidney donation sa7 Figure 13. Sequential evaluation of microscopic hematuria in living kidney donor candidates. S48 Figure 14, Estimated 15-yr incidence (%) of ESKD in the United States according to baseline systolic blood pressure and demographic profile from the CKD-PC.... SSS Figure 15. Estimated lifetime incidence (%) of ESKD in the United States according to baseline systolic blood pressure and demographic profile from the CKD-PC ... S55 Figure 16. Estimated 15-yr incidence (%) of ESKD in the United States according to baseline BMI and demographic profile from the CKD-PC ss8 Figure 17. Estimated lifetime incidence (of ESKD inthe United States according to baseline BMI and demographic profile from the CKD-PC..... Figure 18. Estimated 15-yr incidence (%) of ESKD inthe United States according ‘to non-insulin dependent diabetes mellitus status and demographic profile from the CKD-PC ss9 Figure 19. Estimated lifetime incidence (%) of ESKD in the United States according {0 nonvingulin dependent dabetes melitus status and demographic profile from the CKD-PC...... Figure 20. Estimated 15-yrinckienco(%) of ESKD inthe United States according to baseline smoking status and demographic profile from the CKD-PC set Figure 21. Estimated lifetime incidence (%) of ESKD in the United States according to baseline smoking status and demographic profile from the CKD-PC . ss9 . $60 sez‘TPS01044 St Tansplmtation = pugust 2017 = Volume 101 Nunta \woarspanjonatcom KDIGO EXECUTIVE COMMITTEE Garabed Eknoyan, MD Norbert Lameire, MD, PhD Founding KDIGO Gochairs Bertram L. Kasiske, MD Immediate Past Cochair David C. Wheeler, MD, FRCP Wolfgang C. Winkelmayer, MD, MPH, ScD KDIGO Cachair KDIGO Cochair AliK, Abu-Alfa, MD Zad A. Massy, MD, PhD Olivier Devuyst, MD, PhD Roberto Peccits-Filho, MD, PhD Jorgen Floege, MD Brian J.G. Pereira, MBBS, MD, MBA, John $. Gil, MD, MS Paul E. Stevens, MB, FROP Kunitoshi Iseki, MD Marcello A. Tonelli, MD, SM, FRCPC Andrew 8, Levey, MD Angela Yee-Moon Wang, MD, PaD, FRCP Zhi-Hong Liu, MD Angela C. Webster, MBBS, MM (Clin Epi, PhD KDIGO Statt John Davis, Chiof Executive Officer Danielle Green, Managing Director Michael Cheung, Chief Scientific Officer Tanya Green, Communications Director Melissa McMahan, Programs Director‘TPS01044 (0.2017 Wokers Kae 82 KIDNEY DISEASE: IMPROVING GLOBAL OUTCOMES (KDIGO) LIVING KIDNEY DONOR WORK GROUP: Work Group Cochairs Amrit X. Garg, MD, PhD Western University London, Ganada Work Group Patricia L. Adams, MD Wake Forest School of Medicine Winston-Salem, USA Josefina Albers, MD Instituto Nacional de Ciencias Médicas y Nutricion Sahador Zubién Mexico Gity, Mexico Mohamed A. Bale, MD Mansoura University Mansoura, Egypt Lorenzo Gallon, MD Northwestem University Chicaga, USA Catherine A. Garvey, RN, BA, CCTC University of Minnesota Minneapots, USA Sandeep Guleria, MBBS, MS, NB, FACS Eng}, FRCSEd, FRCS (Glasgow, FROP (Edin) Indraprastna Apofo Hospitals New Det, India Bertram. Kasiske, MD Hennepin County Medical Canter Minneapolis, USA Keista L. Lentine, MD, PhD Saint Louis University School of Medicine Si. Louis, USA Andrew 8. Levey, MD Tufts Medical Center Boston, USA, Philp Kam-Ta0 Li, MD, FCP, FACP Chinese University of Hongkong Hong Kong, China Dorry L. Segev, MD, PhO Johns Hopkins Universty School of Medicine Baltimore, USA ‘Sandra J. Talor, MD Mayo Cinic Rochester, USA Kazurari Tanabe, MD, PhO Tokyo Women's Medica University Tokyo, Japan, Linda Wright, MHSe, MSW University of Toronto Toronto, Ganada Mert G. Zeier, MD, FASN University Hospital Heidelbarg Heidelberg, Germany Evidence Review Team University of Minnesota Department of Medicine Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research Minneapolis, USA Timothy . Wit, MD, MPH, Professor of Medicine and Project Director AreetIshani, MD,MS, Chief, Section of Nephrology, Associate Professor of Medicine, Investigator Yolona Sirin, MD, MS, Assistant Professor of Modicine, Imestigator Michdie Brasure, PhD, MSH, MLIS, Project Manager and Investigator Maureen Carlyle, MPH, Research Assistant‘TPS01044 $3. Tansplmttion = fugust 2017 = Volume 101 Nunta \woarspanjonatcom PREFACE Since the inception of Kidney Disease: Improving Global Outcomes (KDIGO) there has been much discussion over whether to make guideline recommendations when there is litele or no evidence. Combining guideline recommendations that have no supporting evidence swith others that are evidence-based may appear to overrate the former and underrate the latter. Iehas also been argued that making recommendations that have litte or no supporting evidence may inhibit investigators from conducting research to generate needed evidence. On the other hand, caregivers often expeess the nced for guidelines that describe a comprehensive approach to patientcare and do not ignore important isues because there is no evidence. Caregivers still ‘want vo know what a group of experts would do in situations when no evidence is available. KDIGO's approach isto provide comprehensive recommendations with transparency, whereby guideline work groups (WGs) make all recommendations that they deem necessary to inform cohesive patient care while also making it clear which recommendations are supported by evidence and which are not. Guideline recommendations with supporting evidence identified by the Evidence Review Team's (ERT ) systematic review are graded on. the strength of recommendation (Level 1 “We recommend” for strong recommendations or Level 2 “We suggest” for weak recommendations) and on the strength of evidence (A, B, C or D for strong, moderate, weak and very weak, respectively) in accordance to The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group.? ‘Recommendations on topics that were not included in the systematic review or for which no evidence was identified are clearly indicated as “Not Graded.” Ungraded recommendations ‘may be issued by the WG for several reasons, but most commonly because the clinical scenario covered by the recommendation is not one that is amenable to clinical research. These include common sense recommendations wherethere are no reasonable alternatives toa recommended ction, oF when a clinical trialcould never tes the question being addressed. Ungraded recommendations may also be appropriate to offer guidance that is necessary for purely cthieal reasons. ‘The current guideline on the evaluation and care of the living kidney donor is, by the nature ofits subject, heavily populated with ungraded recommendations. A systematic review for relevant evidence was conducted by an independent ERT as per KDIGO protocol. The scope for this review was determined by the WG with input from the public and ERT members, some of whom also had expertise in kidney transplantation. However, the WG was directed to make all recommendations that they felt necessary to ensure a comprehensive evaluation of kidney donor candidates, a safe donation process, and appropriate follow-up care after donation. The ERT worked closely with the WG to assure that clear distinctions were made between the few recommendations that could and should be graded based on the systematic review in keeping with the GRADE criteria, and the many recommendations that needed to remain ungraded. When recommendations from other KDIGO WGs were adapted for this guideline, the prior grading was provided in the rationale, but the statements were not ‘graded as applied here to honor the process of reserving grading solely for evidence drawn, from the systematic review performed to support the current guideline. In addition, the WG was charged with formulating a research agenda, particularly in topic areas for which recommendations were written without adequate evidence but yet such evidence would be possible if there were appropriately designed clinical studies. We recognize, however, that research is an open-ended endeavor and the WG's recommendations for furnce research are not intended to be comprehensive or exclusive.‘TPS01044 (0.2017 Wokers Kae Finally, while developing the current guideline, the WG concluded that the framework for assessing the suitability of candidates for lwving kidney donation needed improvement. ‘This overarching paradigm is grounded on the principle thatthe evaluation of living donor candidates should include a comprehensive determination of risk based on simultaneous consideration of a composite profile of risk factors. Previous guidelines have recommended the assessment of a living donor candidate one risk factor at a time; for example, if a single hhealth characteristic such as the presence of high blood pressure exceeded the acceptance threshold for a transplant program to proceed with donation based on that factor, then the donor candidate was not accepted. In this scenario, how values of single health characteristics alter the risk of postdonation outtomes has been poorly understood, and multiple characteristics were not considered cogether, leading co inconsistent practice in the choice of specific thresholds for a characteristic used to accept or decline a living donor candidate. The WG determined that this, cone-size-mustfitall approach should be replaced by a more comprehensive approach that assessed a combination of demographic, clinical and donation-related factors and their interactions in determining the overall risk. No previous guidelines have advocated this approach to the evaluation of living donor candidates, and there is a paucity of data even to demonstrate its feasibility and applicability. The WG therefore collaborated with the Chronic Kidney Disease-Prognosis Consortium (CKD-PC) to conduct a meta-analysis to produce a ‘comprehensive risk-prediction model. The endpoint for this model, kidney failure requiring dialysis or transplantation, commonly referred to as end-stage kidney disease (ESKD), is an outcome of major importance to donors and healthcare providers. [echould be sressed that the model developed by the CKD-PC, and the online risk prediction tool based on the model, were intended to be a “peoof of concept” exercise and nota final answer tothe question of how to evaluate each donor candidate, The model needs to be properly validated. Although ican provide a useful estimate of ESKD sis in the absence of donation for a donor candidate with a given demographic and health profile, the uncertainty of estimated projected cisk and the need for additional data to improve the model and to use this information to estimate postdonation risk must be emphasized. However, improved versions of the risk prediction too! will not negate this central framework for decision making o its inherent benefits in facilitating wansparency and communication beween caregivers end donoe candidates and in improving the evidence base to suppor the donation decision, We thank the WG Cochairs, Drs. Amit Garg and Krista Lentine, along with all the WG members who volunteered countless hours oftheir time to develop this guideline. We also thank the ERT at the Minneapolis Veterans Administration Center for Chronic Disease Outcomes Research, KDIGO staff, Canadian Blood Services, Canadian Society of Nephrology, Minneapolis Medical Research Foundation, and The Transplantation Society for their support ‘which made tis project possible. We especialfy thank Michael Cheung, who helped facilitate the production of the guideline and to edit the final guideline document. Final, we are very ‘grateful tomembers of the CKD-PC, particularly Drs. Josef Coresh and Morgan Grams, who carried out the analysis that produced the risk assessment tool which underpins the proposed paradigm shift in the evaluation of living kidney donor candidates. David ©. Whesler, MD, FRCP ‘Wolfgang G. Winkelmayer, MD, MPH, ScD KDIGO Cochairs‘TPS01044 Transplantation = ugust 2017 w Vue 101 = Number 8S Ab ABOc ABO! ABPM AOR ADPKD ADTKD AER 4g aus APOLt AST ASTS. pence BM BP BSA GARI cKDPC a cKO CKD-EPI omy ons coss cr cv DBP oTac DIPA By EDTA eGFR eGFRina eGFRin ELISA’ ELISPOT ERBP ERT ESKD FDA Fsos GFR GRADE Hb HBcAb HBsAg HBV Hoy HDLC. HIV HA ABBREVIATIONS AND ACRONYMS antibody |ABO blood group compatible ‘ABO blood group incompatible ‘Ambulatory blood pressure measurement ‘Abumin-to-creatnine ratio ‘Autosomal dominant aolyeystc kidney disease ‘Autosomal dominant tubuiciterstital kelney disease ‘Abumin excretion rate ‘Antigen ‘Atypical hemolytic uremic syndrome Apolporaten L1 ‘American Society of Transplantation ‘American Society of Transplant Surgeons Human chorionic gonadotropin Body mass index Biood pressure Body surtace area (Caring for Australians with Renal impairment Chronic Kidney Disease-Prognosis Consortium Confidence interval Chronic kidney disease CKD Epidemioiogy Collaboration Cytomegalovirus Central nervous system Conference on Guideline Standardization Computed tomoarephy Cartiovascuar disease Diastolic blood pressure Disease Transmission Advisory Committee Diethylenetiamine pentaacetic acid Epstein Bar virus Ethylenediamine tetraacetic acid Estimated glomerular firation rate GFR fom serum creatinine GFR fom serum cystatin © Enzyme-inked immunosorbent assays Enzyme-inked immunosorbent spat European Renal Best Practice Evidence Review Team End-stage kidney disease Food and Drug Administration Focal segmental gomeruosclerosis Glomerular fitraton rate Grading of Recommendations Assessment, Development, and Evaluation Hemoglobin Hepattis B core antibody Hesattis B surace antigen Heoatiis B vis Heoaliis C vius High-density ipoprotein cholesterol Human immunodeficiency virus Human leukocyte antigen \woarspanjonatcom(0.2017 Wokers Kae HR HRCol. IGRA KoIGo KDOQI wie moro MAC mGFR MRL NAT NH NEE NuDAG NOTA, oPTN OR POR PER PHS PicopD PTLD cat ROT RPR SBP TBM 1s us we WHO ‘TPS01044 85 Hazard rato Heath-elated qualty of life Interferon garima release assay Kidney Disease: Improving Global Outcomes Kidney Disease Outcomes Quaity Initiative ‘Kidney paired donation Low-density ipoprotein cholesteral Measured creatinine clearance Major histocompatlty complex Measured glomerular filraton rate Magnetic resonance imaging Nucleic acid testing Natonal Institutes of Health National Kidney Foundation National Living Donor Assistance Center Natonal Organ Transplantation Act (Organ Procurement and Transplantation Network (Odds rao Protein-o-cratinine ratio Protein excretion rate Pubic Heath Service Population, Intervention, Comparator, Outcome, stuly Design, and Duration of follow-up Parathyroid hormone Posttransolant lymphoproltrative disorder Quay of fe Randomized controlled tals, Resid plasma reagn Relative risk Systolic blood pressure ‘Mycobacterium tibercuosis Thin basement membrane nephropathy Tubercuin skin testing United Kingdom United Siates Work Group World Health OrganizationEreocueas KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors Krista L. Lentine, MD, PhD, Bertram L.. Kasiske, MD,? Androw S. Levey, MD,° Patrica L. Adams, MD,* Josefina Albert, MD,° Mohamed A. Bakr, MD,® Lorenzo Gallon, MD, ’ Gatherine A. Garvey, FIN, ‘Sandeep Guieria, MBBS, MS, DNB," Philip Kam-Tao Li, MD, '° Dorty L. Segev, MD, PhD, "' Sandra J. Taler, MD, "? Kazunati Tanabe, MD, PhD," Linda Wright, MHSc, MSW," Martin G. Zeier, MD,'° Michael Cheung, MA,'® and Amit X. Garg, MD, PhD!” Abstract: The 2017 Kidney Disease: improving Giobal Outcomes (KDIGO) Gincal Practice Guidefne.on the Evaltion and Care Cf Lving Kidney Deners sintered to assist medical professionals wna evaluate ving kidney denor candidates and provide care bbeore, during and after donation. The quideine development process folowed the Grades of Recommendation Assessrnent, De- ‘velooment, ad Evakaton (GRADE) approach and guideline recommendations are basad on systematic reviews ofreevant tic les that included critical appraisal of the quality of the evidence and the strength of recommendations. However, mary Fecorrmerdations, for which there was no evidence or no systematic search for evderice was undertaken by the Evidence Review "Team, were ssund as ungraded expert opinion recomendations. The gudsine werk group cencuded that a comprehensive ap proach to rsk assessment shoud replace decsions based on assessments of singe rsk factors in isolation. rignal data areys0s ‘Were undetakan to produce a “proatin-cencept” sk prediction mec fe kichey falar ta support aarmawork or quantitate ik ‘assesement the donor candidate evaluation and defensible shared deciscn making. This Famework is grounded inthe s- ‘multaneous consideration of each candidate's prof of demographic and health characteristics, The processes and trame- "work for the donor candidate evaluation are presented, along wth recommendations for optimal care before, during, and ater donation. Limitations of the evidence are discussed, especialy regarding the lack of defnitve prospective studies ‘and trical outcome trials. Suggestions fr future resoarch, Incldng the neod for continued refinement of long-term sk pre: ‘detion and novel approaches to estimating donation attributable risks, are also provided (Transplantation 2017;101(88): S1-$109) Inciting this document, the folowing format should be used: Kknoy Discase: Improving Global Outcomes (KDIGO) Living Kicnoy Donor Work Group, KEIGO Ginical Practice Guideline on the Evaluation and Gare of Livin Kidney Donors. Transplantation 2017; 1011Supp)S1-S109, ‘caved 10 Feeney 2077 Aecee 20 ere 2017 * santas Unerty Sorat Madea, St Lous MO. " Westem Unirty London ano uiksto Corns, KLL, AKG. coniood ony, ® Herman Coun Masta Cres, Mmazpas > re Cnt, Bon, HA “uo ere Sol of Mtn, Ws Salar, NC * rau cin do Orces Méce y Mutn Scr 2.x, Mo Oy Moen * cou Cnivoty Marsa EE * Noten triers, Chg Une oldies Menage, MN * integrase Aoco Pepa, New at, * Cries Unies of ory Korg, Hong Kor Ci, dunes Unt, Sete Main, ir MOL "mye ine Peres, nL Tego Womens Mecca Unwerty, 790, pen » Urnertye ero, Toon Cot. Uneraty Host berg, dehy, Cama. K0)60, Bras, Boum (Di Cheat Pacts Gut is as upan tana Hao sero st enced in Setorber 2014 sprees eh ee ouch Bre Slrary 207. is doagrad toast doosen mag Hs ior doo 1a Sec of cro xk ob preted as raza on che {cus of managaant Virion act wl ay rd ape ‘car weaning th noo we bins sa sur ae) Iuaions une a welt er hpo o pron Hashes prtecre tng tac rarer Sead i hn Waly Daf De own ened prac ‘Keny DecseInpoig Chabal tous (KACO) aes ore ats fay actor easnab prev cas of ive! thal ia a Pom a tut rain oro pasra, prota or buss ge of @ mare ‘ere wo gap. Al manda oo Work gop 20 rare oct Se land supra sour areata for showing a se rants et nig to pore 2 ae at canis fret Ths baer ied (rua arin bacssad cory. Aree Hora PES aatiyal oan de diame cae pt ono a IED. cour ang taraten cn be ren ah pena on page S08 \Canespancincn ks. Lamha MO, PD fro ct38 Transplantation = August 2017 = Volume 101 Number 3S waarspajamet.com Sippkment gt cone (220) aka he ree Oa: UE etatene [agian th erie ot ar 1h th dR ar roi to HT. {et otis are nto jaamas Wb te marshal cam). (xpyrent 22017KE1GO.eisanopen acco rset roam ‘oft Gone GarmansAibutin fon Gonraca No Devas reo 4.0 ‘SUMMARY OF RECOMMENDATION STATEMENTS. All commendation statements are not graded unless speci fied otherwise. (CHAPTER 1: GOALS OF EVALUATION, FRAMEWORK FOR DECISION-MAKING, AND ROLES AND RESPONSIBILITIES Goals and Principles of Evaluation 1.1: Thedonor candidate's willingness to donate a kidney vol sntaniy wikhout nd presare should be verid. 1.2: The benelia and risks of kidney donation should be assese foreach donor candidate 1.3: The decison to accepe or eaclnde a donor candidate should fll transplant program polis. Donor candidate decision-making should be faitarad through education and counsching_on individualized risks and benefit, methods to: minimize risks, and the ‘eed for postdonation follow-ap. : For an accepted donor canta, plan for donation cae and followup should be formulated 0 minimize Fisks of donation 1.6; For an excluded donor candidate, a plan for any needed care and suppor shouldbe formulated. Framework for Decision-Making 1.7: The donor candidate, the intended recipient, and the transplant program must all agree with the decision 10 proceed with donation in concordance with transplant program polcis and informed consent. 1.8: Transplant program policies must be defensible based on current understanding ofthe risks and benefits of kidney ‘donation, and should apply all donor eandidares eval- tated a the center ach transplant program should establish polices de- scribing psychosocial eiteria that are acceptable for dona tion, including. any program constraints on acceptable relationships becween the donor candidate and the intended recipient. 1.10: All danor candidates should beevaluated using the same criteria, regardless of whether donation is directed wards a designated recipient. 1.1: Each transplant program should establish policies de- scribing medical ereria that are acceptable for dona- tion, addressing when possble, numeric thresholds for shorererm and longterm postdonation risks above ‘which the transplant progeam will not proceed with do- nation. Risks should be expressed as absolute rather than relative risks, 1.12: When possibl, transplant programs shout provide each donor canvidate with individualized quantative ext ‘mates of shor-tenm and long-tem risks from donation, inching recognition of asocated uncerainy, im a man ner that iseasly understned by donor candida. 1.13: Transplant programs should evaluate donor candidate risks in comparson to predetermined thresholds for a ceptance. If'a donor candidate's postdonation risk is 1a: [008 NC ND) whe amiable cunta ad ree werk rot |S popu ots Ie werk cava ba cangud any way er used commer) ‘eth paras tn baad {899 091) -1337/17710108081 ot 10.1carnnenceccennoe 78 above the transplant program's accepeable risk thresh Old, the risk is not aceeptabl for donation. Ifa donor candidate's postdonation risk is below the transplant programs aceeprance threshold, che candidate makes the decision whether or not to proceed with donation, 1.14: Ifa donor candidate is not acceptable, che transplant program should explain the reason for nonaccepeance {othe donor candidate. 1.15: Transplant programs should protoet donor candidate's privaey regarding the evaluation, incaing all consider: tions in the deasion fo donate or not. Roles and Responsibilities 1.16: A mulidisciplinary transplant program team knowl ‘edgeablein kidney donation and transplantation should ‘evaluate, care for, and formulate a plan for donor care including long-term follow-up. 1.17. Transplane programs should minimize conflict of interest by providing at last one key tam member not involved inthe care or evaluation of the intended recipient who evalares the donor candidate and participates in the de- termination of donor acceptance. 1.18: Transplant programs should conductas efficient a do- nor evaluation as possible, meeting the needs of donor ‘candidates, intended recipients and transplant programs. CHAPTER 2: INFORMED CONSENT Process of Informed Consent 2.1: Informed consent for donation should be obeained from the donor candidate in the absence of the intended recip ‘ent, family members and other persons who could ini cence the donation decision. Capacity for Decision Making 2.2: The domor candidate's capacity to provide informed com. sent (iy ability to unmerstand the risks, benefits and ‘consequences of donation) should be confirmed before proveeding with evaluation and donation. 2.3: Substitute decision makers should not be used on behalf ‘of a donor candidate who lacks the capacity to provide informed consent (eg, children or those who are mentally challenged), except under extraordinary circumstances and only after ethical and legal review: Content of Disclosure 2.4: Protocols should be followed to provide each donor can- didae with information on ‘+ Theprocsss of ealmiion, donor acagtanee, and followup + The types of information that may be discovered dur- ing the evaluation, and what the teansplant program will do with such information + Individunize sss, benefits and expected oucemes of the donor evaluation, donation, and postdanation belt, in lading a discussion of tbe uncertain in some outeies(0.2017 Wokers Kae ‘+ Treatment akematives available to transplant cand dates, and average expected outcomes ‘+ How personal heath information will be handled “Availabilty of tansplant program personne! for support ‘Comprehension of Disclosed Information 2.5: The donor candidate's understanding of the ealevantin- formation on the risks and benefits of donation should be confirmed before proceeding with donation, Voluntarisen 2.6: Donor candidates should have adequate time to consider information rdevant to deciding whether they wish o do 2.7: Adoner candidate's decision to withdraw at any stage of| the evaluation process should be respected and supported ia manner that protects confidentiality donor candidate who decides not todonate and has dit ficulty communicating that decision wo the intended re Cipient should be assisted with this communication by the transplant program. 2. (CHAPTER 3: COMPATIBILITY TESTING, INCOMPATIBLE TRANSPLANTATION, AND PAIRED DONATION Evaluation 3.1: Donor ABO blood typing should be performed twice be- fore donation to radace the risk of unintended blood type incompatible transplantation 3.2: Donor blood group A subtype testing should be per- formed when donation is planned t0 recipients with anti-A antibodies. 3.3: Human leukocyte antigen (FLA) ryping for major histo ‘compatibility complex (MEIC) Class (A, B, C) and Class I(DP, DQ, DR) should be performedin donor candidates and theie intended recipients, and donor-specific anti- FILA ansodies shouldbe assessed in intended recipient. Counseling 34s Donor candidates who are ABO blood group oF HLA in ceompatibl with ther intended recipient shoul be informed ‘of availabilty, sks, and benefis of treatment options, in duding kidney paired donation and incompatibility man- fupment srateges. 3.5: Ifa donor candidate and their intend recipient are blood type or crossmatch incompable, ransplantation should be performed only with an effective incompatibility man- agement strategy 3.46:Nondiected donor candidates should be informed of svat, sks and beets of parting kidney paired donation. (CHAPTER 4: PREOPERATIVE EVALUATION AND MANAGEMENT 4.1: Donor candidates should receive guideine-based evalua tion and management usod for other noncardiac surgeries {0 minimize risks of perioperative complications, includ nga detailed history and examination w assess risks or car clic, pulmonary, bleding, anesthesia-elated and other perioperative complications KEIGO Ling Kacey Donor Work Grou 89 4.2: Donor candidates who smoke should beadvsed to quit at least 4 weeks before donation to reduce ther risk of per ‘operative complications, and commit to lifelong. absti- rence to prevent long-term complications. (CHAPTER 5: PREDONATION KIDNEY FUNCTION Evaluation S.A:Donorkie fui should beexpesed a ghmeuar fk ttn ate GER) and nots eum etn contain, ‘s2:Donor GFR should be expensed in Lininper 173 a rater than ei S.:Donor gomeolr ration sate (GFR) should be et tated rerun eae CFR for inka aan, flowing econmndaons from the KDIGO 2012 CXD pune s.4sBomor GER shoul! beconfmedsing one or moe ofthe ‘Showing neasrement, depenting oa erally: «Measured GFR (oiGFR) sing a exogenous flration ‘marker, prerably urinary or plasma cenrance of n- Tin unary or puma ckaratce of fthalamate, ari naty of plasma clearance of "CEDIA, urinary or piso clearance of iobeol, of urinary cerance of Te DWA + Measured crestinne clearance (CsCl * Extimated GER from the combination of serum rat nine and eystin C (CGF) following recommen “Taos from the KDIGO 2013 CKD patechne ‘+ Repeatestimated GFR from serum creatinine (e€GFR.,) 5.5: If there are parenchymal, vascular or urological abnor malities o asymmetry of kidney size on renal imaging, singlekidney GFR should beassessed using radionaces ‘or contrast agents chat are exereted by glomerular filea- tien (eg, "Te-DTPA), Selection ‘5.6: GFR of 9 ml/min pee 1.73 m? or greater should be consid- ‘ced an acceptable eve of kidney function for donation, 5.7: The decision to approve donor candidates with GFR 60 10 89 mL/min per 1.73 m” should be individualized based fon demographic and bealth profile in dation to the ‘transplant program's acceptable risk threshold 5.8 Donor candidates with GER less than 60 mLimin per 41.73 m? should not donate 5.9: When asymmetry in GFR, parenchymal abnormalities, vascular abnormalities, or trological abnormalities are present but do not preclude donation, the more severely affected kidney should be used for donation, Counseling 5.10: We suggest that donor candidates be informed that the fu- ture risk of developing kidney uilre necessitating teat- ment with dialyss or transplantation is slightly higher Iecause of donation; however, average absolute rk in the 15 years following donation remains low. (2C) (CHAPTER 6: PREDONATION ALBUMINURIA Evaluation 6.1: Donor proteinuria should he measured as albuminuria, not total urine protein,$10 Transplantation w August2017 = Voume 101 = Narbar8s 6.2: Intl evaluation of donor albuminuria (secening) should be performed using urine albumin-to-reatinine ratio (ACR) in a random (untimed) urine specimen Donor albuminuria should he confirmed using: * Albumin excretion rate (AER, mg/day [mgd in a timed urine specimen + Repeat ACR if AER cannot be obtained ‘64: Urine AER less than 30 mg/d should be considered an ac ceptable level for donation. The decision w approve danor candidates with AER 30 to 100 me/d should be individvalzed based on demo- traphic and health profile in relation to the transplant program's acceprable risk threshold. 66: Donor caniats with urine AER reterthan 100 meld 6 (CHAPTER 7: PREDONATION HEMATURIA, Evaluation Zl: Donor candidates should be assessed for microscopic hemacuria, 7.2: Donor candidates with persistent microscopic hematuria shold undergo tering fo identify possible causes, which pated ne Men + Urinalysis and urine cure to assess for infection + Cystoscopy and imaging 10 asses for urinary tract smalignasiy + 24-hour urine stone pane to assess for nephrolithiass andir microlians + Kidney biopsy to assess for glomerdar dase (thin basement membrane nephropathy, IgA nephropathy, Alport syndrome) Selection 7.3: Donor candidates with hematuria froma reversible cause that resolves (eg, 2 teated infection) may be acceptable for donation, 7.4: Donor candidates with ig nephropathy should nt donate (CHAPTER 8: KIDNEY STONES. Evaluation 8.1: Donor candidates should be asked about prior kidney ‘ones, and related medical records should be reviewed ifavailabk. 8.2: The imaging performed to assess anatomy before donor nephrectomy. eg, computed tomography angiogram) should be reviewed forthe presence of kidney stones. 8.3:Donor candidates with prior or current kidney stones should he assessed for an underying cause B.ts The acceptance of a donor candidate with prior or cue rent kidney stones should be hased on an assessment of tone recurrence risk and knowledge of the possible consequences of kidney stones after donation Counseling 48.5: Donor candidates and donors with current or prior kid- ‘ney stones should follow general population, evidence based guidelines for the prevention of recurrent stones. waarspajamet.com CHAPTER 9: HYPERURICEMIA, GOUT, AND MINERAL AND BONE DISEASE Evaluation 9.1:Donor candidates should be asked about prior ep odes of gout Counseling 9.2: Donor candidates may be informed that donation is as- sociated with an inerease in serum wre acd concentra tion, which may increase the risk for gout. 9.3: Donor candidates and donors with prior episodes of ‘gout should be informod of recommended methoxls to reduce thee risk of future episodes of gout. CHAPTER 10: PREDONATION BLOOD PRESSURE Evaluation 10.1: Blood pressure should be measured before donation on at least? occasions by nical staff raineinaccurate meas ment nchnique, using equipment calibrated for accuracy. 10.2: When the presence or absence of hypertension ina do- ror candidate is indeterminate based on history and clinic measurements (ee, blood presure Is high noeal fr variable), blood pressure should be further evaluated, using ambulatory blood pressure monitoring (APM) a rept using sandardzel blood pressure measurements. Selection 10.3: Normal blood pressure, as defined by guidelines for the general population in the country or region where dona- tion is planned, is accepeable for donation. 104: Donor candidates with hypertension that can be com trolled to systolic blood pressure less than 140 mm Hig and diastolic blood pressure kss than 90mm Hg using Vor 2 antihypertensive agents, who do no have evi ddence of target organ damage, may be acceptable for do nation. ‘The decision to approve donor candidates with hypertension should be individualized based on demo- {graphic and health profile in relation to the transplant program's acceprable risk threshold. Counseling 10,5: Donor candidates should be counseled om lifestyle inter= ventions t address modifiable sk factors for hyperten- sion and cardiovascular disease, including healthy dit, smoking abstinence, achievement of healthy body weight, and regular exercise according to guidelines forthe gen eral population, These measures should be initiated be- fore Uonation and maintamed lifelon, 10.6; We suggest that donor candidates shoukl be informed that blood pressure may rise with aging, and that dona: tion may accelerate a rise in blood pressure and noed for antihypertensive treatment over expectations with nor: mal aging. (2D) CHAPTER 11: PREDONATION METABOLIC AND LIFESTYLE RISK FACTORS Identification of Metabolic and Lifestyle Risk Factors, 1A: Risk factors for kidney and cardiovascular disease should be identified before donation and addressed by counseling to promote long-term health.(0.2017 Wokers Kae Obesity 11.2: Body mass index (BMI) should be compared based on ‘weight and height measured before donation, and dass Bal based on World [ealth Organization (WHO) criteria for the general population or eacespecfc categories 11.3: The decision to approve donor candidates with obesity and BMI >30 kg/mn= should be individualized based on demographic and health profile in relation ro the trans plane program's acceptable risk threshold. 114: Donor candidates who have had basatric surgery shorld he asses for rs of nephrlthins. Glucose Intolerance 11.5: Donor candidates should be asked about prior digno- sisol diabetes metus, gestational diabetes, and fay bistony of diabetes 11.62 Glycemia should be asesed by fasting blood glucose Sor ghcated hemoglobin (HbA) Blo donation. 11.7: Zhou glucose tolerance oF HAL. testing should be performed in donor candidates wih elevated fasting loo glucoe history of gestational dabees, or fan Aitrfol daheer ra degree dane ta ol should be used woclasify diabetes or peedabers status ting established criteria forthe peneral popelation, "s:Dener candida wiht | ite melon shold 119: The dein to approve donor candidates beso type2 diabetes shouldbe individ on dermegeaphie aa health pee in ration to the transplan program's aeseptabe rk threshold. 1.10: Donor candidates with preaiabetes or type 2 abees shouldbe counseled that thei condition tay progres ‘over time and may lead to end-organ complications. Dystipidemias 1L11: Fasing lipid profile (indding total cholesterol, LDL-C, HDL-C and triglycerides) should be messured as par of an overall candiovascular sk asesmient belore donation. 11.12: The decision o approve donor candidates with dyslip idemia shoukl be individaalized based on demographic fd health profle in relation to the transplant pro trams acceptable risk threshold. ‘Tobacco Use 1134 The we of tobacan proxi should be asesed before 11,14: Donor candidates who use tobacco products should be counseled on the risks of perioperative complications, cancer, cardiopulmonary disease and kidney lure, ‘howd lhe advised to abseain fram ase of obacco prod tuts, and should be refered to a tobacco cessation sup- port program if possible 11.15: The decision to approve donor candidates who are ac: tive tobacco users should be individualized based on ‘demographic and health profile in relation tothe trans plant program’s acceptable risk threshold, (CHAPTER 12: PREVENTING INFECTION ‘TRANSMISSION Evaluation 112.1: Risk for human immunodeficiency vis (HIN), hepatitis B virus (HBY), and hepatitis C vieus (HCV) infections should be assersed before donation, KDIGO Lng Kthey Donor Work Group sn 12.2: Donor candidates should be assessed for fcrors ass dated with an increased lketinood of endemic or unex pected infections, including geographic, seasonal, ‘ccuparional, animal and environmental exposure. 123: Donor eanudtes should completa unaljsisand testing for HIV, HBN, HCY, extomegaloviris (CMV), pst Bar virus (EBV), and Treponema palihon phils. 124: [finde by regional eprlemilogy or individual stor domo cada sou ope eg foe Nets Sunn tuberadosis, Stongylades, Trypanosoma cru Wiest Nile vis, Hstoplasmoss, andor Coceidionycoss 12.5: Transplant programe should develop prosools wo sereen donor candidates for emerying infections inconsutaion svt local public health specials. 12.6:Ingenenl, donor infection hk factor and microbiologjeal assesment should be performed or updated 3x close in time to donation as posible. Foe HN HBV and HCN, Screening could be curent within 28 days of donation Selection 12.7: Ifa donor candidate is found to have a potentially trans missible infection, then the donor candidate, intended recipient and transplant program team should weigh the risks and benefits of proceeding with donation. CHAPTER 13: CANCER SCREENING Evaluation 13.1: Donor eandidates should undergo cancer screening con sistent with nial practice guidelines for the country or region where the donor candidate resides. Transplant ‘programs should ensure that screening is curren accord Ing to guideline criteria at che time of donation, Selection 132: peneeal, donor candidates with active malignancy shorld be excaded from donation. kn some cases ofa tive malignancy with low ransmision ky acear man Srsment plan and minimal rik tothe donor, danation inay be considered. 133: Alidney wath sll simple (Bosniak cystcan be eft inthe donor, particularly thre are compelling reasons for donating the contralateral kidney. 134s Daonaen ofa ancy witha Bouin Irena cyt should froced only alter demsament forthe presence of eli Exponent sprasone, and aleenions on the preop- cen computed oma san or mag Kidney with cyec renal cll carcinoma," 135: Dono cnates wth igh ade Bosniak nals (I or higher or smal (a) rea el carcinoma curable by Depectomy may be acura for donation on case byrose bass 13.6: Donor candidates with a hizry of weal cance that has 2 low rk of ranmision or eurrence nay be accept ate for donation on a case hyease basis. (CHAPTER 14: EVALUATION OF GENETIC KIDNEY DISEASE Evaluation Ml: Donor candidates should be asked about their family history of kidney disease, and when present, the typeS12 Transplantation w= August2017 = Voume 101 = Nrbar 8s ‘of disease, time of onset and extra-renal manifestations ‘associated with the disease. ‘When the intended meipicne is genetically related tothe donor candidate, the enise ofthe intended roapient’skid- ney failure should be determined whenever posable. The intended recipient should eonsentto share this medical in- formation withthe donor evaluation tar, and with the donor candidate fc could affect the decision to donate. Selection 142. 14.3: Donorcandidatesfound rohavea genetickidney disease that can cause kidney failure should not donate Counseling 1H.4: Donoreandaes mas provide informed eonset fr e- reac etn finest aspartfthae evaluation, Dor Candidates shoud be informed ofthe posable fas re ceiving diagnos optic ide dessin a any impacton thet ability ty ebsin health i instance. 14.5: In eases wheseieretaiog wncerain whether the doen Calida has a genetic kidney disease and wheter the Given the low incidence of perioperative mortality, estimates for predonation characteristics that alter the rsk of perioper- ative death are imprecise. For example, in this same study, predonation history of hypertension was associated with a 1 in 270 risk of 90-day mortality. However, this estimate was based only on 2 observed deaths, and the estimate would hhave substantially changed if 1 more or less death was ob- serveds the 95% Cl for the estimate was abo wide, ranging from 1 in 75 to 1 in 2220, Thus, evenifa transplant program defines an acceptable risk threshold for perinephrectomy lity (for example, an incidence less than 1 in 1000), i will be dificult a this time to reliably determine a given do- nor candidate's estimated risk of this outcome according to thei profile of predonation characteristics. ‘With respect to perioperative complications, the ERT iden: tified 2 systematic reviews that examined perinephrectomy ntcomes in relation to demographic and health character istics of accepted donors. The ERT rated the quality ofthis evidence as very low (Evidence Report Tables 6 and 7, SDC, hupullinks.ivw.com/TP/B434). In one review, a group of selected older donors (mean age, 66 yearss range, ‘ansplant program’ threshold for Postdonation Risk % accoptable postdonation risk Candidate A candidate 8 KDIGO Lng Kthey Donor Work Group sz 60110 85 years at donation) didnot differ statistically from 4 group of younger donors in their operative time, intraop- erative blood loss, and length of hospital stay. In both views, groups of selected obese donors (mean BMI of 34.5 kg/m’; range 32-39 ke/m”} did not differ statistically fram groups of nonobese donors in their rates af perioper- ative complications, operative time, blood loss and length of hospital stay 2° Since then a large US sly examined predonation charac- teristics associated with a higher risk of donor nephrectamy- related complications (es asesed through administrative data rather than adjudication, using a composite outcome of digestive, respiratory, procedural, urinary, hemorrhage, Fnfectious of cardiac complictions In this study, where cach donor candidate charactriatie was considered by itself (rather than as combination of characteristics, complica- tion rates were higher in. men versus women (9.6% vs 7.2%); among African Americans (10.4%) and whites (8.7%) compared with other racial groups (6.3%), among donors without private insurance (8.5%) compared with those who had privat insurance (739%); and among, donors ‘with hypectension (17.79%) compared with those without hy- pertasion (7.9%) A subsequent study integrated national US donor registry data from 2008 to 2012 with administrative records fom a consortium of 98 academic Hospitals and found that 16.8% of donors experienced a diagnosis or procedure for a perinephrcetomy complication, most commonly gastoin- testinal 4.4%), bleeding (3.0%), respiratory (2.5%), and surpicalfanesthesia-rlated injures (2.4%). Major compl- cations, defined as Clavien severity level 4 or 5, were ident- fied in 2.5% of donors. Aftr adjustment for demographic, clinical (including, comoebdities), procedure, and center factors, compared with white donors, Afican Americans hhad signifcanly higher risks (P< 0,05) of experiencing any complication (18.2% vs 15.5%) and of experienc- jing major complications (3.7% vs 2.2%). Other significant corteates of major complications included obesity, pre- donation blood disorders, psychiatric conditions, and ro- hoe nephrectomy, while greter annual hospital volume predicted lower risk. Transplant [ew onde [Translator scm airr 2candante decides ‘wheter to occa andidte¢ FFIGURES. Framawotk to acceptor decina donor cancdateshasodon a raneplant programs thrshol of acneptablepostdonstion sk. The {Gecko by the transplant program fo acceptor daclne a dorcrcarddateis gourded on wfwsheraninchicuals estmeted pestcenaton sk fs above o below the thesia sot (dotted ing by the transplant progam, The treshold may vary acosstrareplant programs, but the sae {tyeshad should apply oa donoy candidates at cach program: Poraxaineo, cancidate A (arden) would be aczoptzble boca tho estinatod ‘Projected postdonaton risk far below the threshold, Candidate B (yellow) coud be accepted with causton because the estimated projected postdcnalion risk is Gose but below the threshold, and candidate C (2d) would be unacoeplzie because the esiated postionatin [Projected sks far above tn tiveshold“Transplantation w August 2017 « Vue 101 = Nurbar 8 As future data become availahle, it may become possible {for transplant programs to estimate the risk of well-defined, setious perioperative complications according to 2 donor candidate's individual profile of bascline characteristics, and to compace these estimates to a threshold of acceptable risk to inform donor acceptance decisions Long-term Outcomes Donating a kidney is a decision with lifetime implications forthe donor. While there are many outcomes to consider af- ter kidney donation, a central outcome dircetly related to having, one kidney eemoved isthe long-term risk of develop- ing kidney failure requiring dialysis or transplantation, com- monly referred to a8 ESKD. Donor candidates often have a good understanding of the health effects of kidney failure, as their reason to donate ito treat the kidney failure oftheir intended recipient. For these reasons, we have grounded a quantitative Framework for medical evaluation and accep- tance of donor candidates on the long-term risk of post- donation kidney failure. Each donor candidate has a longterm isk (cumulative incidence) of developing kidney failure that is influenced by the combination of risks conferred by their demographic and health characteristics at the time of evaluation plus risk attributable to donation (Figure 4). Demographic character- istics include age, sex, and race. Health characteristics clude glomerular filtration rate (GFR), albuminuria, BMI, BP, diabetes status, smoking history, family history of kidney disease, and other factors. The risk attributable to donation may also vary according to demographic and health ch acteristics. Minimizing the lifetime risk of kidney failure accepted donors is important to safeguard the practice, re- fgardless of the degree to which it can be established that donation contributed to the risk of kidney failure. ‘Challenges to determining the postdonation lifetime risk of| kkidney failure based on current studies include limitations of study follow-up (the largest studies followed most donors for 3 2 ‘Transplant program's threshold for ) oe 1 eee i a ; = cmssnes Gwe waarspajamet.com less than 2 decades rather than for thee lifetime) 2° The risk of kidney failure after donation isnonlincar,and isexpected to be higher later (2:10 years) than earlier (<10 years) after donation.»! When the WG was convened, 2 recent studies reported that the risk of kidney failure is higher in donors compared with risk among nondonors with similar base- line demographics. The ERT assessed the quality of evi- dence from these 2 studies as moderate (Table 2 of Slinin et al?}°0%2 Available data suggest thatthe average donation: attributable risk of kidney failure is approximately 27 per 10000 (0.3%) at 15 years,?® but there is substantial uncer tainty in the estimate, and there are not sufficient data to pro- ject lifetime donation-atributable risk. Furthermore, the ‘extent to which donation-attriburable risk varies according to individual health characteristics is not known, *"* al- though available evidence suggests there is higher donation attributable risks in some subgroups, sch Afran Americans ‘compared with white donors? "Existing lange popalation-hased studies can help estimate the long-term risk of treated kidney failure in the absence of donators, based on a candidate's predonation health char acteristics. Furthermore, if the risk of kidney failure attrib uutable to donation becomes more precisely understood in relation to an individual's profile of baseline characteris- ties, then demographic-related, health status related, and donation-attibutable risks can be aggregated to project in di d estimates of long-terms risks of postdonation kidney failure To help advance this paradigm, we enlisted the help of the CKD-Prognosis Consortium (CKD-PC) to develop a tool t0 project the 15-year and lifetime incidence of kidney failure in the absence of donation based on demographic and health characteristics at the time of evaluation in low-risk persons from large population cohorts. CKD-PG is a research group composed of investigators who analyze large cohort data and perform collaborative meta-analyses. The methods and results of these analyses are reviewed briefly here and ‘Tanslat poem ‘decines sonar “andidte 1) arpa program ‘ees donor 2) candidate decides ‘ahaha roe [HL bonstonatriutable rik may vary by demorraphic and heath characteris) _Aezwet rik rted eat chris nthe bree of donation (64.6, blood pressure, BM smoking) (B_emographic related (ae, sea] skin the absence of donation FIGURE 4, Framewk to acceptor dene dorks candidates based on arareplant program's treshold of acceptable projected Hetine bk ‘of Kchey fie, quantified as the aggregats of rk telatadto demographic and heath profile and dora -arbuaabiersis. The deckion by the transplant program whether to accapt or deine a donercandeales graunded cn the caneldle's estimated postdenation Hetmerisk Incuaing ested skin the absence of Goration isk rested to democraphic ard heal characteristics as denoted in be and beige, spect) and estmatad risk tributabie to donaion xonn). EM), body mass Index GFR, glomerular fitaon rao