A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

NO_LONGER_AVAILABLE

Conditions studied: Renal Transplantation

In brief

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

Key facts

Study ID

NCT00719225

Run by

Bristol-Myers Squibb

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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