Aims: Many immunosuppressive drugs are prescribed as twice-daily dosing. Simplified once-daily dosing of the entire drug regimen can improve treatment satisfaction for patients. We examined the safety, efficacy, and treatment satisfaction of a simplified once-daily immunosuppressive regimen using extended-release tacrolimus, sirolimus, and corticosteroids.
Methods: This study was a prospective, multicenter, controlled, cohort trial. Adult kidney transplant patients with a stable renal function were eligible if they had received transplants more than 3 months prior to study enrollment, and were taking tacrolimus. Efficacy failure, safety, and renal function were evaluated until 6 months post-conversion. Measurements of treatment satisfaction were performed.
Results: A total of 160 kidney recipients were in the intention-to-treat (ITT) population. No graft loss and one patient death at home were reported. The incidence of treated biopsy-confirmed acute rejection until 6 months post-conversion was 0.62%. The mean estimated glomerular filtration rate of was not significantly changed (P > 0.050) but the 24-hour urinary excretion of protein before conversion was significantly lower (87.1 ± 140.9 mg/day) than that at 6 months post-conversion (206.5 ± 433.5 mg/day, P < 0.001) in 140 per-protocol (PP) population. Among the ITT population, overall 95 (59.4%) had a type of adverse event (AE) and 28 patients (17.5%) had a serious AE. The patients demonstrated a significant improvement in treatment satisfaction (P < 0.001).
Conclusion: The kidney recipients who received the once-daily immunosuppressive regimen expressed a statistically significant improvement in satisfaction without the additional risks of adverse effects or efficacy failure.