A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients

Phase 4 Completed 228 enrolled Novartis

RandomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.

Timeline

Start: 2006-06
Primary completion: 2008-12
Completion: 2008-12

Publications

Langer RM, Hene R, Vitko S, Christiaans M, Tedesco-Silva H Jr, Ciechanowski K, Cassuto E, Rostaing L, Vilatoba M, Machein U, Ulbricht B, Junge G, Dong G, Pascual J. Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation. Transpl Int. 2012 May;25(5):592-602. doi: 10.1111/j.1432-2277.2012.01465.x. Epub 2012 Mar 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Everolimus	Small molecule	1.5 mg	—
Comparator	Tacrolimus	Small molecule	0.1 mg/kg	—
Comparator	Basiliximab	Monoclonal antibody	20 mg	Intravenous

Indications

No indication recorded.