Impact of calcineurin-inhibitor conversion to mTOR inhibitor on renal allograft function in a prednisone-free regimen.
Chhabra D, Alvarado A, et al.American Journal of Transplantation 2013;13(11):2902-11
Aims
To investigate the outcomes and feasibility of converting kidney recipients from tacrolimus (Tac) to sirolimus (SL) 1 year post transplant.
Interventions
All patients were induced with alemtuzumab and methylprednisolone with rapid steroid elimination. At 12 months patients either continued on Tac, or were converted to SL.
Participants
200 renal transplant recipients.
Outcomes
The primary outcome was biopsy proven acute rejection at 24 months postrandomisation. The secondary outcomes included patient and graft survival, glomerular filtration rate (eGFR), donor-specific antibody levels and the incidence of adverse events such as infections, malignancies, proteinuria, haematological abnormalities and hyperlipidemia.
Follow-up
The mean post transplant follow up time for the Tac group was 41±14.2 months and 41.2±16 months fo
CET Conclusions
This is a relatively large randomised controlled trial of 200 patients who were induced with alemtuzumab and underwent rapid steroid elimination, and were maintained on tacrolimus and mycophenolate mofetil. At 12 months they were randomised to either stay on tacrolimus or convert to sirolimus. There was no increased incidence of biopsy proven acute rejection following randomisation, nor was there any difference in patient or graft survival, and in particular the GFR at 24 months after randomisation. The mean follow-up for all patients was 3.5 years following transplantation. Thus although this strategy is feasible it is perhaps disappointing that no improvement in renal function was seen.
Data analysis
Available case analysis
Trial registration
ClinicalTrials.gov - NCT00866879