Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen

Summary

The purpose of this study is to demonstrate non-inferiority of an advagraf based immunosuppressive regimen with slower dose tapering and lower starting dose of Advagraf compared with a standard Advagraf-based immunosuppressive regimen in de novo renal transplantation. Non inferiority will be assessed by a combined study endpoint consisting of the development of biopsy-proven rejection of BANFF class Ia or higher and/or graft loss and/or patient death within the first six months after renal transplantation.

Timeline

Start

2014-09

Primary completion

2020-02

Completion

2025-12

Drugs

Indications