Belatacept to Prevent Organ Rejection in Kidney Transplant Patients

Phase 2 Terminated 5 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN) · collab

NaSingle-groupOpen-labelTreatment

Summary

Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

Timeline

Start: 2006-12
Primary completion: 2010-02
Completion: 2010-02

Publications

Background Vincenti F, Larsen C, Durrbach A, Wekerle T, Nashan B, Blancho G, Lang P, Grinyo J, Halloran PF, Solez K, Hagerty D, Levy E, Zhou W, Natarajan K, Charpentier B; Belatacept Study Group. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005 Aug 25;353(8):770-81. doi: 10.1056/NEJMoa050085.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE)	Protein / enzyme biologic	1.5 mg/kg	Intravenous
Subject	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous
Subject	Sirolimus	Small molecule	4 mg	Oral
Background	Acetaminophen	Small molecule	650 mg	Oral
Background	Diphenhydramine	Unknown	—	Oral
Background	Methylprednisolone	Other / unclassified	0.5 mg/kg	Intravenous
Background	Prednisone	Other / unclassified	0.5 mg/kg	Oral

Indications

No indication recorded.