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A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
No longer available
CT.gov ID
NCT00719225
Collaborator
(none)
7
Locations

Study Details

Study Description

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 Phase

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Green Hospital La Jolla California United States 92037
    2 Office Of Dr. Allan Kirk Atlanta Georgia United States 30322
    3 Acadiana Renal Physicians New Iberia Louisiana United States 70563
    4 Tulane Abdominal Transplant Institute New Orleans Louisiana United States 70112
    5 UNC Kidney Center Chapel Hill North Carolina United States 27514
    6 The Transplant Center Of The Lehigh Valley Allentown Pennsylvania United States 18103
    7 Texas Transplant Physician'S Group San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00719225
    Other Study ID Numbers:
    • IM103-056
    First Posted:
    Jul 21, 2008
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Abatacept

    Study Results

    No Results Posted as of Nov 23, 2021