Multicenter Clinical Investigation for the Safety and Efficacy of Advagrafⓡ (Extended Release Tacrolimus) versus Prografⓡ (Tacrolimus) in De Novo Kidney Recipients after 1 Month of Transplantation: Preliminary Results

Abstract

Background: Compliance from kidney transplant recipients might improve with less frequent doses of immunosuppressant drugs. We describe the development of an extended-release formulation of tacrolimus that enables taking the drug just once a day, instead of the current twice a day tacrolimus formulation.

Methods: We performed a prospective, open-label, 1:1 randomized, and multicenter study. Patients received Prograf(R) (Astellas Inc.) twice a day for 1 month post-transplantation. The patients of the investigational group converted to a dose of Advagraf(R) (Astellas Inc.) given once a day. We evaluated the efficacy, safety, and patient satisfaction of both groups.

Result: Within 5 months after conversion to Advagraf, the incidence of biopsy-confirmed acute rejection was 0%, while patient and graft survival was 100%. We could not find differences of the patients` estimated glomerular filtration rate (eGFR) between the Prograf and Advagraf treated groups 1∼6 months post-transplantation. The safety profile and satisfaction profiles (immunosuppressant therapy barrier scale) were also equivalent between the treated groups.

Conclusions: The preliminary results of this study support the safety, efficacy, and patient satisfaction from a single daily formulation of tacrolimus (Advagraf(R)).