A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
NCT ID: NCT00719225
Last Updated: 2021-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Belatacept
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* EBV negative
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
EAP Investigator Requests
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM103-056
Identifier Type: -
Identifier Source: org_study_id