Albano, Laetitia and Banas, Bernhard and Klempnauer, Juergen L. and Glyda, Maciej and Viklicky, Ondrej and Kamar, Nassim (2013) OSAKA Trial: A Randomized, Controlled Trial Comparing Tacrolimus QD and BD in Kidney Transplantation. TRANSPLANTATION, 96 (10). pp. 897-903. ISSN 0041-1337, 1534-6080
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Background. The once-daily (QD), prolonged-release formulation of tacrolimus has been shown to improve adherence versus twice-daily (BD) tacrolimus. Treatment nonadherence in transplant recipients has been associated with poor graft outcomes. Methods. This open-label, parallel-group study randomized adults with end-stage renal disease undergoing primary kidney transplantation or retransplantation to an initial dose of tacrolimus BD 0.2 mg/kg per day (Arm 1; n=309), QD 0.2 mg/kg per day (Arm 2; n=302), QD 0.3 mg/kg per day (Arm 3; n=304) all with mycophenolate mofetil and corticosteroids (tapered) over 24 weeks, or tacrolimus QD 0.2 mg/kg per day with mycophenolate mofetil, basiliximab, and corticosteroids given only perioperatively (Arm 4; n=283). The primary composite endpoint (efficacy failure; per protocol set) was defined as graft loss, biopsy-confirmed acute rejection, or graft dysfunction at week 24. Graft dysfunction was defined as estimated glomerular filtration rate Modification of Diet in Renal Disease-4 formula of less than 40 mL/min/1.73 m(2). The prespecified noninferiority margin was 12.5%. Results. The per protocol set included 976 patients: 237, 263, 246, and 230 patients in Arms 1 to 4, respectively. Noninferiority of the composite endpoint was demonstrated for Arm 2 versus Arm 1; Kaplan-Meier estimates of efficacy failure were 42.2% and 40.6%, respectively (difference, -1.6%; 95% confidence interval [CI], -12.2% to 9.0%). Noninferiority to Arm 1 was not confirmed for Arm 3 (difference, -3.5%; 95% CI, -13.6% to 6.6%) or Arm 4 (difference, -7.1%; 95% CI, -16.1% to 1.9%). Graft dysfunction (estimated glomerular filtration rate <40 mL/min/1.73 m(2)) was the main determinant of composite-endpoint efficacy failure across all arms. Conclusions. In patients representative of the European kidney transplant population, tacrolimus QD-based immunosuppression (0.2 mg/kg/day), without induction, showed similar efficacy to 0.2 mg/kg per day tacrolimus BD.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ONCE-DAILY TACROLIMUS; RENAL-TRANSPLANTATION; CALCINEURIN INHIBITORS; PHASE-III; RECIPIENTS; IMMUNOSUPPRESSION; ADHERENCE; VARIABILITY; FORMULATION; REGIMENS; Tacrolimus; Kidney transplantation; Extended-criteria donor; Composite endpoint for graft failure |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 26 Mar 2020 07:02 |
| Last Modified: | 26 Mar 2020 07:02 |
| URI: | https://pred.uni-regensburg.de/id/eprint/15649 |
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