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

Completed · Phase 2

Conditions studied: Disorder Related to Renal Transplantation

In brief

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

Key facts

Study ID

NCT00455013

Run by

Bristol-Myers Squibb

People needed

93

Starts

2007-07-01

Expected to finish

2012-08-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ucsf — San Francisco, California, United States
• Denver Nephrology, Pc — Denver, Colorado, United States
• University Of Colorado Health Sciences Center — Denver, Colorado, United States
• Medical College Of Georgia — Augusta, Georgia, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• Henry Ford Hospital — Detriot, Michigan, United States
• Albany Medical College — Albany, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• University Of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Local Institution — Bologna, Bologna, Italy
• Local Institution — Brescia, Italy
• Local Institution — Padova, Italy
• Local Institution — Roma, Italy
• Local Institution — Barcelona, Spain
• Local Institution — Seville, Spain

Full record on ClinicalTrials.gov

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