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).
Yang SS, Choib JY, et alTransplantation Proceedings 2015; 47(3): 617-621
Aims
To evaluate the safety and efficacy of standard-dose tacrolimus modified-release (TAC-MR) once daily versus tacrolimus (TAC) twice daily in stable renal transplant recipients.
Interventions
Patients in the control group received TAC twice daily while the study group received TAC-MR once daily.
Participants
90 adult kidney transplant patients (aged >20 years), transplanted at least 12 months before enrolment and maintained on a daily dose of tacrolimus for at least 12 weeks before the start of the study.
Outcomes
The primary outcome measured were the incidence of adverse events (AEs) and serious adverse events (SAEs). Secondary outcomes were estimated glomerular filtration rate (eGFR), blood pressure, level of hemoglobin A1c (HbA1c), blood concentration of tacrolimus, dose compliance, graft survival, patient survival, acute rejection and examination of health condition by SF-36 and Subject Questionnaire (SQ).
Follow-up
24 weeks
CET Conclusions
This study reports 99 stable renal transplant recipients who were at least 12 months after transplantation and who were randomised to receive the modified release tacrolimus once daily or remain on standard twice daily tacrolimus. There was no difference in the incidence of adverse events in either group, nor in the incidence of biopsy proven acute rejection. Graft survival, patient survival and quality of life questionnaire (SF-36) results were the same in both groups. This is an important observation as previous studies have not dealt with quality of life. Nevertheless this is more evidence that the modified release form of tacrolimus is safe and equally effective at least within the limits of the follow up at 6 months.
Data analysis
Strict intention-to-treat analysis
Trial registration
None