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A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00719225
Expanded Access Status : No longer available
First Posted : July 21, 2008
Last Update Posted : November 23, 2021
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Renal Transplantation Drug: Belatacept

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Belatacept for Renal Allograft Recipients: A Compassionate Use Program

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept

Intervention Details:
  • Drug: Belatacept
    IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
    Other Names:
    • LEA29Y
    • BMS-224818

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719225

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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Georgia
Office Of Dr. Allan Kirk
Atlanta, Georgia, United States, 30322
United States, Louisiana
Acadiana Renal Physicians
New Iberia, Louisiana, United States, 70563
Tulane Abdominal Transplant Institute
New Orleans, Louisiana, United States, 70112
United States, North Carolina
UNC Kidney Center
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
The Transplant Center Of The Lehigh Valley
Allentown, Pennsylvania, United States, 18103
United States, Texas
Texas Transplant Physician'S Group
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00719225    
Other Study ID Numbers: IM103-056
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents