Belatacept to Prevent Organ Rejection in Kidney Transplant Patients

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Abatacept; Antilymphocyte Serum; Everolimus; Glucocorticoids; Immunoglobulins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sirolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Receiving first renal (e.g., kidney) transplant

• Transplant is from a non-HLA-identical living donor

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• Positive for anti-human globulin (AHG) or T-cell cross-match with the donor

• Receiving multiple-organ transplant

• History of cancer within the 5 years prior to study entry. Patients who have certain nonmelanoma skin cancers are not excluded

• Human immunodeficiency virus (HIV) infected

• Hepatitis B (HBV) or C (HCV) virus infected

• Other active infections

• Active tuberculosis (TB) infection within the 3 years prior to study entry

• Pregnancy or breastfeeding