A Single Center, Open-label, Randomized Pilot Study to Evaluate the Safety and Efficacy of Tacrolimus Modified Release, ADVAGRAF, Versus Tacrolimus Twice Daily, PROGRAF, in Stable Renal Recipients (SINGLE)

Background. Compliance with immunosuppressive regimens may affect clinical outcomes in renal transplant recipients. The aim of this study was to assess the safety and efficacy of standard-dose tacrolimus modified-release (TAC-MR) once daily versus tacrolimus (TAP twice daily in stable renal transplant recipients. Methods. Ninety-nine stable renal transplant recipients were randomized to receive standard-dose tacrolimus twice daily or standard-dose modified-release tacrolimus once daily on a 1:1 (mg:mg) basis. The primary end point was the incidence of adverse events (AEs) in both groups. Secondary end points included biopsy-proven acute rejection, graft survival, patient survival, clinical indicators, and change in score of questionnaire. Results. The incidence of AEs was not different between the TAC and TAC-MR groups (56.0% vs 53.1%, P >.05). There were no significant differences in mean calculated glomerular filtration rate, blood pressure, glycosylated hemoglobulin (HbA1c), blood concentration of tacrolimus, and drug compliance. The scores of all items in the 36-item short form health survey (SF-36) were not different between groups, except for vitality. With respect to the subject questionnaire, there was no difference in question scores between the two treatment groups. Conclusion. A regimen of TAC-MR once daily can be considered as an effective and safe alternative formulation of tacrolimus in stable renal transplant patients.