- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00719225
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
November 18, 2021 updated by: Bristol-Myers Squibb
Belatacept for Renal Allograft Recipients: A Compassionate Use Program
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
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- Scripps Green Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Office Of Dr. Allan Kirk
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Louisiana
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New Iberia, Louisiana, United States, 70563
- Acadiana Renal Physicians
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New Orleans, Louisiana, United States, 70112
- Tulane Abdominal Transplant Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- UNC Kidney Center
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- The Transplant Center Of The Lehigh Valley
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Texas
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San Antonio, Texas, United States, 78229
- Texas Transplant Physician'S Group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 17, 2008
First Submitted That Met QC Criteria
July 17, 2008
First Posted (Estimate)
July 21, 2008
Study Record Updates
Last Update Posted (Actual)
November 23, 2021
Last Update Submitted That Met QC Criteria
November 18, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM103-056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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