Renal Transplantation
Conditions
Brief summary
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 nonrenal 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
Interventions
DRUGBelatacept
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Sponsors
Bristol-Myers Squibb
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
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
Countries
United States
Outcome results
None listed