A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

Phase 2 Completed 173 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

Timeline

Start: 2007-01
Primary completion: 2009-06
Completion: 2013-06

Publications

Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyo J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous
Comparator	Cyclosporine	Peptide	—	Oral
Comparator	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.