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

Trial 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

Eligibility

• 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

• 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

Detailed Description

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

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