Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients

Phase 3 Completed 80 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelPrevention

Summary

This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.

Timeline

Start: 2003-11
Primary completion: 2005-11
Completion: —

Publications

Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, Shaw LM, Munir L, Ulbricht B, Cooper M; CRADUS09 Study Group. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation. 2008 Mar 27;85(6):821-6. doi: 10.1097/TP.0b013e318166927b.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	—	—

Indications

No indication recorded.