A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
- Conditions
- Renal Transplantation
- Registration Number
- NCT00719225
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Office Of Dr. Allan Kirk
🇺🇸Atlanta, Georgia, United States
Acadiana Renal Physicians
🇺🇸New Iberia, Louisiana, United States
Tulane Abdominal Transplant Institute
🇺🇸New Orleans, Louisiana, United States
UNC Kidney Center
🇺🇸Chapel Hill, North Carolina, United States
The Transplant Center Of The Lehigh Valley
🇺🇸Allentown, Pennsylvania, United States
Texas Transplant Physician'S Group
🇺🇸San Antonio, Texas, United States
Scripps Green Hospital🇺🇸La Jolla, California, United States