A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Living or deceased donor renal allograft

• Men and women, 18 to 70 years old

• Subjects who have received a de novo kidney transplant, who have completed the initial study treatment through Month 12, and are willing to sign informed consent will be eligible to continue into the long term extension phase

Exclusion Criteria:

• Pregnant or breastfeeding women

• Epstein Barr Virus (EBV) negative serology

• First time renal transplant with panel reactive antibody (PRA) ≥ 50% or retransplantation with PRA > 30%

• Graft loss due to AR

• Positive T-cell or B-cell crossmatch

• Recipients/donors with HIV or hepatitis B/C

• Active tuberculosis (TB)

• Immunosuppressive therapy within 1 year of enrollment

• UNOS ECD organs will be excluded

• Body mass index (BMI) > 35 kg/m²

• Subjects who have developed any malignancy (other than non-melanoma skin cancer) or other medical condition that, in the investigator's opinion, should not be treated with an experimental immunosuppressive drug like belatacept