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

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Office Of Dr. Allan Kirk
    • Louisiana
      • New Iberia, Louisiana, United States, 70563
        • Acadiana Renal Physicians
      • New Orleans, Louisiana, United States, 70112
        • Tulane Abdominal Transplant Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Kidney Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • The Transplant Center Of The Lehigh Valley
    • Texas
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Physician'S Group

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

Bristol-Myers Squibb

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.

Helpful Links

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.

Subscribe