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Clinical Pharmacokinetics of Once-Daily Prolonged-Release Tacrolimus (Graceptor) in De Novo Kidney Transplantation

Y. Nakagawa, K. Saito, M. Ikeda, M. Tasaki, K. Takahashi

Division of Urology, Department of Regenerative and Transplant Medicine, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan

Meeting: 2013 American Transplant Congress

Abstract number: B943

(Introduction)

Graceptor (GCT) is a new formulation of tacrolimus (TRL), allows once-daily administration while showing similar efficacy and safety to the conventional Prograf (PGF), which is prescribed twice daily. Furthermore, it is not known whether there are any pharmacokinetic differences between once- versus twice daily tacrolimus. Our study sought to compare short-term therapeutic drug monitoring (TDM) of GCT and PGF in de novo kidney transplants.

(PATIENTS AND METHODS)

Fourty de novo kidney transplant recipients were treated with once-daily or twice-daily tacrolimus, TRL and standard immunosuppresive induction therapy. This study compared the pharmacokinetics of tacrolimus

Group1: 20 recipients were treated once-daily formulations of tacrolimus (Graceptor (GCT) ). A target trough is 8-10 ng/ml at 1month

Group2: 20 recipients were treated once-daily formulations of tacrolimus (Prograf (PGF)) A target trough is 10-12 ng/ml at 1month

(RESULTS)

1,Patient (100%versus 100%) and graft survival (100% versus 100%) at 1year were no different between the groups. Patients of GCT experienced not significantly less CNI toxicity (10% versus 25%, P=0.061) than those in PGF. However, there were significantly less than those in PGF at CMV infection (25% versus 45%, P=0.061).

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To cite this abstract in AMA style:

Nakagawa Y, Saito K, Ikeda M, Tasaki M, Takahashi K. Clinical Pharmacokinetics of Once-Daily Prolonged-Release Tacrolimus (Graceptor) in De Novo Kidney Transplantation [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/clinical-pharmacokinetics-of-once-daily-prolonged-release-tacrolimus-graceptor-in-de-novo-kidney-transplantation/. Accessed May 14, 2025.

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