NIV Congres

Background Calcineurin inhibitors (CNI) are essential immunosuppressives in the early phase after renal transplantation. As they are nephrotoxic, withdrawal at a certain timepoint has been a challenge ever since their introduction. We aimed to analyse the influence of CNI withdrawal at 6 months after transplantation on long term results.

Methods 212 patients transplanted between 1997 and 1999 participated in a randomized multicentre trial. All patients were initially treated with Mycophenolate mofetil (MMF) , Cyclosporine A (CsA) and prednisone (pred). At six months after transplantation, 63 patients were randomised for MMF/Pred (group 1), 76 for MMF/CsA (group 2) and 73 for MMF/CsA/Pred (group 3). Follow-up data until November 2012 were extracted from the NOTR database.

Results At randomisation groups were not significantly different for recipient, donor and transplantation characteristics. Within 6 months after randomisation 24 patients had a rejection episode (28,6%, 6.8%, and 1.4% in groups 1, 2, and 3, respectively, p<0.001). The frequency of CsA use at 1 and 2 years after transplantation was 12.7% and 19.0% in group1, 97.4% and 86.8% in group 2, and 95.9% and 79.5% in group 3. At the end of follow-up 67 patients have died with a functioning graft, 43 patients have lost their graft, and 102 are alive with a functioning graft. Graft survival censored for death was 67%, 76% and 81% in groups 1,2 and 3: difference not significant. In multivariate analysis, graft survival censored for death was significantly associated with serum creatinine at 6 months after transplantation and with acute rejection after randomisation, but not with randomisation group. Also patient survival and uncensored graft survival did not differ between the groups.

Conclusion This intention to treat analysis did not show long term graft or patient survival benefit for patients withdrawn from calcineurin inhibitor treatment at six months after kidney transplantation.