Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

Phase 4 Completed 121 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupOpen-labelPrevention

Summary

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Timeline

Start: 2006-09
Primary completion: 2010-04
Completion: 2010-05

Outcome

Met primary endpoint

paper was significantly higher with sirolimus versus CNI treatment (+3.0 vs. -1.4 mL/min/1.73 m(2) , respectively; p = 0.004). PMID 22776430 ↗

registry LEAST_SQUARES_MEAN Sirolimus (SRL): 3.03 (Standard Error 1.29) mL/min/1.73m^2 NCT00369382 ↗

Publications

Zuckermann A, Keogh A, Crespo-Leiro MG, Mancini D, Vilchez FG, Almenar L, Brozena S, Eisen H, Tai SS, Kushwaha S. Randomized controlled trial of sirolimus conversion in cardiac transplant recipients with renal insufficiency. Am J Transplant. 2012 Sep;12(9):2487-97. doi: 10.1111/j.1600-6143.2012.04131.x. Epub 2012 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	—	—
Subject	Sirolimus	Small molecule	1 mg	Oral
Subject	Sirolimus	Small molecule	2 mg	Oral
Comparator	Tacrolimus	Small molecule	—	—