Tacrolimus Once Daily (ADVAGRAF) Versus Twice Daily (PROGRAF) in de Novo Renal Transplantation: A Randomized Phase III Study

Tacrolimus Once Daily (ADVAGRAF) Versus Twice Daily (PROGRAF) in de Novo Renal Transplantation: A Randomized Phase III Study

Author Kraemer, B. K. Google Scholar
Charpentier, B. Google Scholar
Backman, L. Google Scholar
Silva, H. Tedesco Autor UNIFESP Google Scholar
Mondragon-Ramirez, G. Google Scholar
Cassuto-Viguier, E. Google Scholar
Mourad, G. Google Scholar
Sola, R. Google Scholar
Rigotti, P. Google Scholar
Ortuno Mirete, J. Google Scholar
Tacrolimus Prolonged Release Rena Google Scholar
Institution Univ Heidelberg
Univ Paris Sud
Univ Uppsala Hosp
Sahlgrens Univ Hosp
Universidade Federal de São Paulo (UNIFESP)
Inst Mexicano Transplantes
Serv Nephrol
Hop Lapeyronie
Fundacio Puigvert
Azienda Osped Padova
Hosp Ramon & Cajal
Abstract This multicenter, 1:1-randomized, parallel-group, noninferiority study compared the efficacy and safety of twice-daily tacrolimus (Tacrolimus BID; Prograf) and once-daily tacrolimus prolonged release (Tacrolimus QD; Advagraf), combined with steroids and low-dose mycophenolate mofetil without antibody induction, in 667 de novo kidney transplant recipients. A double-blind, double-dummy 24-week period was followed by an open extension of up to 12 months posttransplant. Biopsy-proven acute rejection rate at 24 weeks (primary endpoint, per-protocol analysis) was 15.8% for Tacrolimus BID versus 20.4% for Tacrolimus QD (p = 0.182; treatment difference 4.5%, 95% confidence interval-1.8%, 10.9%, just outside the prespecified 10% noninferiority margin). Kaplan-Meier 12-month patient and graft survival rates were 97.5% and 92.8% for Tacrolimus BID and 96.9% and 91.5% for QD. Both treatment groups showed equally well-maintained renal function at 12 months (mean creatinine clearance approximately 67 mL/min) and similar adverse event profiles. Overall results obtained with either Tacrolimus QD or BID, without antibody induction, were good, supporting use of the once-daily formulation as an effective alternative to the established twice-daily formulation.
Keywords Biopsy-proven acute rejection
immunosuppression
kidney transplantation
noninferiority study
prolonged-release tacrolimus
tacrolimus
Language English
Sponsor Astellas Pharma Europe Ltd, Staines, UK
Date 2010-12-01
Published in American Journal of Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 10, n. 12, p. 2632-2643, 2010.
ISSN 1600-6135 (Sherpa/Romeo, impact factor)
Publisher Wiley-Blackwell
Extent 2632-2643
Origin http://dx.doi.org/10.1111/j.1600-6143.2010.03256.x
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000284698400014
URI http://repositorio.unifesp.br/handle/11600/33093

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