Protocol Calcineurin Inhibitor (CNI) Weaning

Phase 3 Terminated 16 enrolled Nantes University Hospital

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of this study is to demonstrate the benefit of the withdrawal of Tacrolimus (Prograf®) on renal function in patients one year after the end of the weaning period. The secondary objectives will focus on assessing the risks and consequences of withdrawal of Tacrolimus (Prograf®).

Timeline

Start: 2011-05
Primary completion: 2015-05
Completion: 2015-05

Publications

Masset C, Dantal J, Soulillou JP, Walencik A, Delbos F, Brouard S, Giral M; Nantes DIVAT Consortium. Case Report: Long-term observations from the tacrolimus weaning randomized clinical trial depicts the challenging aspects for determination of low-immunological risk patients. Front Immunol. 2022 Nov 28;13:1021481. doi: 10.3389/fimmu.2022.1021481. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tacrolimus	Small molecule	—	—

Indications

No indication recorded.