A 1-year Comparison of Generic Tacrolimus (Tacni®) and Prograf® in Renal Transplant Patients: A Retrospective Matched Group Analysis

Abstract

Introduction: The 1-year-outcome of adult patients treated with Tacni® or Prograf® following de novo renal transplantation, including patient survival, graft loss, Biopsy Proven Acute Rejection (BPAR) and serious adverse events were compared. 186 patients who underwent their first renal transplantation between 2011 and 2014 were included in a retrospective matched group analysis (91 patients treated with Tacni® which were compared with a matched control group (n=95).Material and Methods: This was a retrospective study of two different time cohorts of patients who underwent kidney transplantation at Sahlgrenska University Hospital. Data was obtained from patient charts and from the local quality registry. Patients from the two groups were matched in a group matching fashion. The matching was based upon the patient’s age and gender, age of the donor, living/deceased donor and Cold Ischemia Time (CIT).Results: The two groups were well matched for living donor transplants; gender; donor and recipient age. The combined endpoint of freedom from BPAR, graft loss and death 12 months post-transplantation was 85% in the P-group and 86% in the T-group (p=0.90). There was one death in the T-group, which was not related to the drug (p=1.00). Graft survival at 12 months was similar, 99% in both groups (p=0.97). The BPAR at 12 months was 12% (T) and 14% (P), respectively (p=0.72). The measured GFR at 12 months was also similar, 54.5 and 56.0 ml/min/1.73 m2 (p=0.59). There were no significant differences in Tacrolimus levels.Conclusion: One year after transplantation, generic Tacrolimus is no different to the original version. Both drugs show good efficacy, the safety is comparable and the drug concentrations do not differ.