Impact of Early Conversion From Tacrolimus to Sirolimus on Chronic Allograft Changes in Kidney Recipients on Rapid Steroid Withdrawal.
Heilman R, Cortese LC, et al.Transplantation 93 (1):47-53, 2012
Aims
To explore whether conversion from tacrolimus to sirolimus would result in less interstitial fibrosis and tubular atrophy (IFTA) and other chronic changes on protocol biopsies performed at 1 year and 2 years.
Interventions
Conversion of tacrolimus to sirolimus versus continuing tacrolimus at 1-month posttransplant. All patients received induction with rabbit antithymocyte globulin (Thymoglobulin), mycophenolate mofetil (MMF) and corticosteroids withdrawal after 4 days.
Participants
122 renal transplant recipients.
Outcomes
The primary outcome was chronic changes IFTA on protocol biopsy. Other outcomes included the dose of MMF, acute rejection and the frequency of rejection during 2 years.
Follow-up
2 years
CET Conclusions
In this prospective randomised trial of conversion from tacrolimus to sirolimus 1 month after transplantation in patients on rapid steroid withdrawal, there was no evidence that chronic changes on protocol biopsies did not progress during the first two years after conversion to sirolimus. The trial was terminated before completion of the recruitment target because of an increased incidence of acute rejection in the patients converted to sirolimus.
Data analysis
Available case analysis
Quality notes
This is a subgroup analysis of a previous publication of the same RCT: Heilman RL. Younan K. Wadei HM. Mai ML. Reddy KS. Chakkera HA. Gonwa TA. Results of a Prospective Randomized Trial of Sirolimus Conversion in Kidney Transplant Recipients on Early Corticosteroid Withdrawal. Transplantation. 92(7): 767-773, 2011. The methodological quality assessment was based on the previous paper.
Trial registration
NCT00170053 (ClinicalTrials.gov)