Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• Subject is a first-time recipient of a kidney transplant from a deceased donor.

• Specific donor criteria

Exclusion Criteria:

• Donor age <10 years

• Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)

• Subjects with a positive T-cell lymphocytotoxic crossmatch.

• Subjects who are positive for Hepatitis B or C, or HIV

• Active tuberculosis

• History of cancer in the last 5 years

• History of substance abuse

• Specific laboratory results are exclusionary

• Mammography suspicious for cancer

• Allergy to iodine

• For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)