Pilot Study Comparing the Efficacy, Safety, Convertibility, and Tacrolimus Trough Levels of Twice-Daily Tacrolimus (Prograf) to Once-Daily Tacrolimus (Advagraf) Among Standard-Risk Kidney Transplant Patients at the National Kidney and Transplant Institute

Abstract

Background: Recently, a once-daily formulation of tacrolimus (Advagraf) was released in the Philippines. Studies have shown that these 2 formulations are bioequivalent at a 1:1 conversion. This study aims to determine the efficacy, safety, convertibility, and tacrolimus trough level of once-daily tacrolimus at the end of 6 months post transplant.

Methods: This is a randomized study among standard-risk primary kidney transplant patients performed at the National Kidney and Transplant Institute, Philippines. A total of 40 patients completed the 6-month follow-up. Patients in Group A who failed to meet the criteria for conversion to once-daily tacrolimus were considered to have reached the end of the study, while patients who satisfied the conversion criteria will be followed up for an additional 6 months.

Results: Baseline characteristics were similar in both groups. The area under the curve, maximum concentration, time to achieve the maximum concentration, and the coefficient of variation were similar. The twice-daily tacrolimus (Prograf) group patients had significantly higher mean tacrolimus trough levels than the Group B once-daily tacrolimus patients. An increase of a once-daily tacrolimus mean dose of 8% was required to achieve a therapeutic drug level post conversion. The graft and patient survival were 100%. There was no biopsy-proven acute rejection noted either both group.

Conclusion: In conclusion, conversion from twice-daily tacrolimus to once-daily tacrolimus in kidney transplant in both de novo and converted patients after KT is safe, ensuring greater stability of drug blood concentrations than the standard form. The results also suggest an 8% increase when converting stable KT patients from twice-daily tacrolimus to once-daily tacrolimus.