A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
Belatacept for Renal Allograft Recipients: A Compassionate Use Program
1 other identifier
expanded_access
N/A
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedNovember 23, 2021
November 1, 2021
July 17, 2008
November 18, 2021
Conditions
Interventions
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Scripps Green Hospital
La Jolla, California, 92037, United States
Office Of Dr. Allan Kirk
Atlanta, Georgia, 30322, United States
Acadiana Renal Physicians
New Iberia, Louisiana, 70563, United States
Tulane Abdominal Transplant Institute
New Orleans, Louisiana, 70112, United States
UNC Kidney Center
Chapel Hill, North Carolina, 27514, United States
The Transplant Center Of The Lehigh Valley
Allentown, Pennsylvania, 18103, United States
Texas Transplant Physician'S Group
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 21, 2008
Last Updated
November 23, 2021
Record last verified: 2021-11