Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

Phase 4 Completed 86 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.

Timeline

Start: 2005-08
Primary completion: 2009-01
Completion: 2009-01

Outcome

Met primary endpoint

paper Yearly NMSC rate was significantly lower with sirolimus (1.31 vs. 2.48 lesions/patient-year; p = 0.022). PMID 22420843 ↗

Publications

Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sirolimus	Small molecule	—	—
Comparator	Cyclosporine	Peptide	—	—
Comparator	Tacrolimus	Small molecule	—	—