1. USRDS Clinical Indicators of Renal Allograft Loss Lawrence Y.C. Agodoa, MD FACP Jon J. Snyder, MS Bertram L. Kasiske, MD Allan J. Collins, MD FACP United States Renal Data System Department of Health and Human Services National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases

2. USRDS Time Trends in Transplants in the US

3. USRDS Renal Allograft Survival Probabilities, US; adjusted for age, gender, race and primary disease

4. USRDS Causes of Renal Allograft Loss Acute – Mechanical - Immune mediated Early - Immune mediated - Non-immune Late- Non-immune I M M U N O L O G I C NON- IMMUNOLOGIC Clinical Indicators

5. USRDS Study Objectives  Determine how various clinical indicators affect graft survival in the cadaveric and living donor transplant recipients.  Three outcomes were considered: n Graft failure (including death) n Death-censored graft failure (graft loss without death) n Death with functioning graft  Due to factors unique to cadaveric vs. living donor recipients, cadaveric transplant recipients are analyzed separately from recipients of living donor transplants.

6. USRDS Analytical Methods  The effects of various factors on graft failure, death-censored graft failure, and death with function were analyzed for the living donor and cadaveric donor populations using Cox proportional hazards models.  The results include: n Trends in first-year graft survival n Trends in conditional half-lives. n Overall survival curves n Relative risks associated with each covariate.  All results are adjusted for all other covariates.

7. USRDS Population  All first, renal-only transplants in the United States from 1995 to 2001 with known recipient age and known donor type: n N=76,467 Living Donor Transplants: 28,469 Cadaveric Donor Transplants: 47,998  Follow-up through 9/30/2002.

8. USRDS Trends in First-Year Graft Survival Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

9. USRDS Trends in Conditional* Half-Lives Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure *Conditional on 1 year graft survival

10. USRDS Estimated Graft Survival 1995-2001 Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

11. USRDS Clinical Indicators  Factors Associated with both cadaveric and living donor transplants  Factors associated with cadaveric transplants  Factors associated with living donor transplants

12. USRDS Clinical Indicators: Recipient Age Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

13. USRDS Clinical Indicators: Recipient Gender Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * p< 0.05

14. USRDS Clinical Indicators: Recipient Race Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * * * * * p<0.05

15. USRDS Clinical Indicators : Recipient Hispanic Ethnicity Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * P < 0.05

16. USRDS Clinical Indicators: Primary Cause of Renal Failure Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * * * * * * ** * * * * * * p < 0.05

17. USRDS Clinical Indicators: Pre-transplant Serology: Hepatitis Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * p < 0.05

18. USRDS Clinical Indicators: Recipient Education Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * p < 0.05

19. USRDS Clinical Indicators: Recipient Employment Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * p < 0.05

20. USRDS Clinical Indicators: Prior Dialysis Time Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

21. USRDS Clinical Indicators: Donor Age Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

22. USRDS Clinical Indicators: Donor Gender Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * p<0.05

23. USRDS Clinical Indicators: Donor Race Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * * p<0.05

24. USRDS Clinical Indicators: HLA Mismatches Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

25. USRDS Clinical Indicators: Recipient Body Mass Index (BMI) Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure

26. USRDS Clinical Indicators: PRA Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * p<0.05

27. USRDS Clinical Indicators: CMV Matching Cadaveric Living Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * * * * p<0.05

28. USRDS Clinical Indicators  Factors Associated with both cadaveric and living donor transplants  Factors associated with cadaveric transplants  Factors associated with living donor transplants

29. USRDS Cadaveric-Specific Clinical Indicators: Donor Traumatic Cause of Death Death-Censored Graft FailureDeath with FunctionGraft Failure * ** * p<0.05

30. USRDS Cadaveric-Specific Clinical Indicators: Cold Ischemia Time Death-Censored Graft FailureDeath with FunctionGraft Failure

31. USRDS Cadaveric-Specific Clinical Indicators: Donor Co-morbid Conditions Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * p<0.05

32. USRDS Clinical Indicators  Factors Associated with both cadaveric and living donor transplants  Factors associated with cadaveric transplants  Factors associated with living donor transplants

33. USRDS Living Donor Clinical Indicators: Donor-Recipient Relationship Death-Censored Graft FailureDeath with FunctionGraft Failure * * * * * * * p<0.05

34. USRDS Clinical Indicators for transplant Outcome: Summary and Conclusions Clinical Indicators that promote allograft loss include:  Older age (recipient and donor)  Race and ethnicity (recipient and donor)  Education and employment status  Primary Cause of Renal Disease  Longer time on dialysis prior to transplant  Hepatitis C and CMV positivity  HLA mismatches