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Novel Once‐Daily Extended‐Release Tacrolimus (LCPT) Versus Twice‐Daily Tacrolimus in De Novo Kidney Transplants: One‐Year Results of Phase III, Double‐Blind, Randomized Trial

Budde, K. ; Bunnapradist, S. ; Grinyo, J. M. ; Ciechanowski, K. ; Denny, J. E. ; Silva, H. T. ; Rostaing, L.

American journal of transplantation, 2014-12, Vol.14 (12), p.2796-2806 [Periódico revisado por pares]

Hoboken, NJ: Wiley

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Título:
Novel Once‐Daily Extended‐Release Tacrolimus (LCPT) Versus Twice‐Daily Tacrolimus in De Novo Kidney Transplants: One‐Year Results of Phase III, Double‐Blind, Randomized Trial
Autor: Budde, K. ; Bunnapradist, S. ; Grinyo, J. M. ; Ciechanowski, K. ; Denny, J. E. ; Silva, H. T. ; Rostaing, L.
Assuntos: Adult ; Antibacterial agents ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Biological and medical sciences ; calcineurin inhibitor: tacrolimus ; clinical research/practice ; clinical trial ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Glomerular Filtration Rate ; Graft Rejection - drug therapy ; Graft Rejection - etiology ; Graft Survival ; Humans ; immunosuppressant ; immunosuppression/immune modulation ; Immunosuppressive Agents - administration & dosage ; Kidney Failure, Chronic - surgery ; Kidney Function Tests ; Kidney Transplantation - adverse effects ; kidney transplantation/nephrology ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Postoperative Complications ; Prognosis ; Risk Factors ; Side effects ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Tacrolimus - administration & dosage ; Time Factors ; Transplants & implants
É parte de: American journal of transplantation, 2014-12, Vol.14 (12), p.2796-2806
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Descrição: This Phase III randomized trial examined efficacy and safety of a novel once‐daily extended‐release tacrolimus formulation (LCP‐Tacro [LCPT]) versus twice‐daily tacrolimus in de novo kidney transplantation. Primary efficacy end point was proportion of patients with treatment failure (death, graft failure, biopsy‐proven acute rejection or lost to follow‐up) within 12 months. Starting doses were, LCPT: 0.17 mg/kg/day and tacrolimus twice‐daily: 0.1 mg/kg/day; 543 patients were randomized, LCPT: n = 268; tacrolimus twice‐daily: n = 275. At 12 months treatment failure was LCPT: 18.3% and tacrolimus twice‐daily: 19.6%; the upper 95% CI of the treatment difference was +5.27%, below the predefined +10% noninferiority criteria. There were no significant differences in the incidence of individual efficacy events or adverse events. Target tacrolimus trough levels were more rapidly achieved in the LCPT group. Following initial dose, 36.6% of patients in the LCPT group had rapidly attained trough levels within 6–11 ng/mL versus 18.5% of tacrolimus twice‐daily patients; majority of tacrolimus twice‐daily patients (74.7%) had troughs <6 ng/mL compared with 33.5% in the LCPT group. Overall, cumulative study dose was 14% lower for LCPT. Results suggest that use of once‐daily LCPT in de novo kidney transplantation is efficacious and safe. Lower LCPT dose reflects the improved absorption provided by the novel formulation. One‐year results from this Phase III randomized, double‐blind trial show that novel once‐daily extended‐release tacrolimus formulation affords rapid achievement of therapeutic tacrolimus trough levels, and it has noninferior efficacy and similar safety and renal function outcomes as twice‐daily tacrolimus in de novo kidney transplant recipients, at a lower tacrolimus dose.
Editor: Hoboken, NJ: Wiley
Idioma: Inglês

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Novel Once‐Daily Extended‐Release Tacrolimus (LCPT) Versus Twice‐Daily Tacrolimus in De Novo Kidney Transplants: One‐Year Results of Phase III, Double‐Blind, Randomized Trial

Budde, K. ; Bunnapradist, S. ; Grinyo, J. M. ; Ciechanowski, K. ; Denny, J. E. ; Silva, H. T. ; Rostaing, L.

Hoboken, NJ: Wiley

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