A comparative, randomized trial of concentration-controlled sirolimus combined with reduced-dose tacrolimus or standard-dose tacrolimus in renal allograft recipients.
Bechstein WO, Paczek L, et al.Transplantation Proceedings 2013; 45(6): 2133-2140.
Aims
To investigate the clinical safety and efficacy of sirolimus plus reduced dose tacrolimus (rTAC) in renal allograft recipients.
Interventions
Patients were randomized before transplantation to receive corticosteroids and sirolimus oral solution in combination with either rTAC or standard dose tacrolimus.
Participants
128 primary or secondary renal allograft recipients.
Outcomes
The primary outcome was graft function assessed by calculated creatinine clearance at 6 months post transplant. The secondary outcomes include graft function as assessed by serum creatinine, the incidence of biopsy confirmed acute rejection (BCAR) and presumptive acute rejections (AR), the time to first BCAR, the severity of AR, patient and graft survival, the incidence of infection, histologically confirmed lymphoproliferative disease or malignancy, new onset diabetes mellitus and premature withdrawal from study medication.
Follow-up
6 months.
CET Conclusions
In this randomised trial of modest quality, sirolimus plus either reduced dose tacrolimus or standard dose tacrolimus were compared. There was a positive creatinine clearance difference at 6 months but no difference in serum creatinine or patient or graft survival. There was more acute rejection with the reduced tacrolimus dose. The authors claim that the reduced tacrolimus regimen with sirolimus produced effective immunosuppression and was associated with improved creatinine clearance. I think this is a rather questionable conclusion and one should note that the study was funded by Wyeth and also writing support provided by Wyeth. Thus one should regard the conclusions of the authors as questionable.
Data analysis
Per protocol analysis
Trial registration
Not reported.