To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either: - unable to construct an adequate immunosuppression regimen due to non-renal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR - at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy
Drug: Belatacept
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Other Name: LEA29Y
Other Name: BMS-224818
Please call 800-398-9157 for information on this study
Inclusion Criteria:
- Men and women of age 18 years or older inclusive
- Recipient of a renal allograft for at least ≥ 2 months
- EBV positive
- Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
- Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
- Contraindication to CNIs and/or m-TOR inhibitors
OR
- At imminent risk of losing allograft kidney due to nephrotoxicity
- Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min)
- And no other renal replacement therapy
- Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA
Exclusion Criteria:
- Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks
- EBV negative
Scripps Green Hospital
La Jolla, California, 92037
Office Of Dr. Allan Kirk
Atlanta, Georgia, 30322
Local Institution
New Iberia, Louisiana, 70563
Tulane Abdominal Transplant
New Orleans, Louisiana, 70112
The Transplant Center Of The Lehigh Valley
Allentown, Pennsylvania, 18103
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb