Minimization Of Maintenance Immunosuppressive Therapy After Renal Transplantation Comparing Cyclosporine A/Azathioprine Or Cyclosporine A/Mycophenolate Mofetil Bitherapy To Cyclosporine A Monotherapy: A 10-Year Postrandomization Follow-Up Study

Long-term outcomes in renal transplant recipients withdrawn from steroid and submitted to further minimization of immunosuppressive regimen after 1year are lacking. In this multicenter study, 204 low immunological risk kidney transplant recipients were randomized 14.2 +/- 3.7months post-transplantation to receive either cyclosporine A (CsA)+azathioprine (AZA; n=53), CsA+mycophenolate mofetil (MMF; n=53), or CsA monotherapy (n=98). At 3years postrandomization, the occurrence of biopsy for graft dysfunction was similar in bitherapy and monotherapy groups (21/106 vs. 26/98; P=0.25). At 10years postrandomization, patients' survival was 100%, 94.2%, and 95.8% (P=0.25), and death-censored graft survival was 94.9%, 94.7%, and 95.2% (P=0.34) in AZA, MMF, and CsA groups, respectively. Mean estimated glomerular filtration rate was 70.4 +/- 31.1, 60.1 +/- 22.2, and 60.1 +/- 19.0ml/min/1.73m(2), respectively (P=0.16). The incidence of biopsy-proven acute rejection was 1.4%/year in the whole cohort. None of the patients developed polyomavirus-associated nephropathy. The main cause of graft loss (n=12) was chronic antibody-mediated rejection (n=6). De novo donor-specific antibodies were detected in 13% of AZA-, 21% of MMF-, and 14% of CsA-treated patients (P=0.29). CsA monotherapy after 1year is safe and associated with prolonged graft survival in well-selected renal transplant recipient ( number: 980654).