Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

Phase 4 Completed 80 enrolled Vanderbilt University Genzyme, a Sanofi Company · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

Timeline

Start: 2004-04
Primary completion: —
Completion: 2005-03

Publications

Background Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6. doi: 10.1097/00007890-200210270-00002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sirolimus	Small molecule	5 mg	—

Indications

No indication recorded.