Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation.
Oh C K, Huh KH, et al.Yonsei Medical Journal 2014; 55(5): 1341-1347.
Aims
To investigate the safety, efficacy and patient satisfaction of kidney transplant recipients converting from twice daily tacrolimus to once daily tacrolimus.
Interventions
Patients were administered twice daily tacrolimus with prednisolone and mycophenolate mofetil and were either converted to the same dose of extended release tacrolimus once daily or were maintained on tacrolimus twice daily.
Participants
60 primary kidney transplant recipients.
Outcomes
The primary outcome was the efficacy failure rate at six months post-transplant, including mortality graft failure, treatment for biopsy confirmed acute rejection (BCAR) or loss to follow up. The secondary outcomes were patient and graft survival, incidence of BCAR, estimated glomerular filtration rate and the amount of proteinuria in 24-hour urine at six months. Patient satisfaction was defined by the authors as the barriers to immunosuppressant adherence.
Follow-up
6 months.
CET Conclusions
The report describes an open label, non-inferiority trial comparing once-daily with twice-daily tacrolimus in kidney transplant recipients who were converted at 1 month posttransplant. Sample size calculations showed that a minimum of 25 patients per group were needed and 60 patients were randomised. The short term data at 6 months showed that once-daily tacrolimus was non-inferior to twice daily tacrolimus for the primary composite efficacy endpoint (death, graft failure, treated biopsy confirmed acute rejection or loss to follow up) and any of the secondary outcomes. The authors provided very little detailed information about the adverse events, which showed similar rates of (serious) adverse events. Authors reported the mean scores for the barriers to drug adherence questionnaire which was equal between the two groups but based on the information provided in the paper one cannot judge whether the patients perceived barriers to adherence or not. The efficacy results are similar to the conclusion of a systematic review that concluded that once-daily tacrolimus is as effective as twice-daily tacrolimus up to 12 months posttransplant (Ho et al, Transplantation 2013;95: 1120-1128).
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov – NCT01742624