Long-term outcomes after cyclosporine or mycophenolate withdrawal in kidney transplantation - results from an aborted trial.
Asberg A, Apeland T, et al.Clinical Transplantation. 2013; 27(2): 151-156
Aims
To compare the long term outcomes for stable kidney transplant patients on triple immunosuppression withdrawn from cyclosporine (CsA) or mycophenolate mofetil (MMF).
Interventions
The withdrawal group received MMF and prednisolone with a dosage of no less than 2.0 g/d after four weeks. The control group received CsA and prednisolone with trough concentrations maintained between 75 and 125 ng/mL.
Participants
39 kidney transplant recipients, transplanted more than one year prior to randomization, with low immunological risk and on triple immunosuppression (CsA, MMF and prednisolone). Immunological risk was defined as recipients without panel reactive antibodies (PRA<20, no acute rejection episodes prior
Outcomes
Acute rejection, time to rejection after the study start, dose of MMF or CsA at 3 months (mg/d), trough concentration of mycophenolic acid (mg/L) or CsA (ng/mL) at 3 months, graft loss, chronic allograft failure/rejection, recurrence of kidney disease, retransplantation and death.
Follow-up
8 years.
CET Conclusions
This is a very interesting report of a study that has previously remained unreported despite its premature abortion in 2007. After inclusion of less than a sixth the intended number of patients, the study was aborted by the data safety monitoring board, due to an unacceptable rate of acute rejection in one arm. Renal transplant patients at least one year after transplantation, stable on triple therapy with cyclosporine, mycophenolate and steroids were randomised to either cyclosporine or mycophenolate withdrawal. There were no acute rejection episodes in the mycophenolate withdrawal group, however there were six (30%) in the cyclosporine withdrawal group. Given the small numbers included, it was not possible to draw a conclusion about the study’s primary endpoint, the difference in GFR at 12 months.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT NCT00148252