Status:
COMPLETED
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Disorder Related to Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 regim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00455013
Start Date
July 1 2007
End Date
August 1 2012
Last Update
June 9 2014
Active Locations (17)
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1
Ucsf
San Francisco, California, United States, 94143
2
Denver Nephrology, Pc
Denver, Colorado, United States, 80218
3
University Of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
4
Medical College Of Georgia
Augusta, Georgia, United States, 30912