Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.

Phase 3 Completed Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelPrevention

Summary

The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.

Timeline

Start: 2004-09
Primary completion: 2006-07
Completion: —

Publications

Results Ross H, Pflugfelder P, Haddad H, Cantarovich M, White M, Ignaszewski A, Howlett J, Vaillancourt M, Dorent R, Burton JR; CADENCE Study Group (CAnadian Pilot Sutdy to Determine Safe and Effective Dosing of Neoral and CErtican in Stable Cardiac Transplant Recipients). Reduction of cyclosporine following the introduction of everolimus in maintenance heart transplant recipients: a pilot study. Transpl Int. 2010 Jan;23(1):31-7. doi: 10.1111/j.1432-2277.2009.00940.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	1.5 mg	—

Indications

No indication recorded.