Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf®) in kidney transplantation: a phase IV study.

Abstract

Background: Transplant recipients are given an immunosuppressive regimen such as tacrolimus to prevent organ rejection. Suprotac® is a generic tacrolimus that is utilized in kidney transplantation regimen in Iran. This post-market study was conducted to evaluate the safety and efficacy of Suprotac® in comparison with Prograf®.

Methods: In this two-armed, open-label, parallel, active-controlled, and cohort study, de novo kidney transplant recipients aging 18 to 65 years were prescribed Suprotac® or Prograf® as part of the immunosuppressant protocol. The primary outcome was comparing the mean estimated glomerular filtration rate (eGFR) at month 12. The secondary outcomes were the assessment of patient and graft survival, acute rejections during hospitalization, tacrolimus dose, trough concentration, and trough concentration/dose (C/D) ratio, and adverse events (AEs) during the study period.

Results: A total of 201 patients were enrolled in this study. At discharge, the eGFR was lower in the Suprotac® group compared to the Prograf® group (51.70 ml/min/1.73m2 and 57.48 ml/min/1.73m2, respectively; p = 0.042). However, at month 12, there was no significant difference in mean eGFR between the two groups (58.94 ml/min/1.73m2 and 59.78 ml/min/1.73m2, respectively; p = 0.772). Other outcomes, including patient and graft survival, acute rejection during hospitalization, tacrolimus dose, trough concentration, and C/D ratio, and overall incidence of AEs were similar between the two groups (p > 0.05).

Conclusion: The efficacy and safety profile of the generic tacrolimus were shown to be comparable to the reference tacrolimus at month 12.