A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

• Conditions: Renal Transplantation

• Registration Number: NCT00719225
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (7)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

Tulane Abdominal Transplant Institute; 🇺🇸 New Orleans, Louisiana, United States

Office Of Dr. Allan Kirk; 🇺🇸 Atlanta, Georgia, United States

The Transplant Center Of The Lehigh Valley; 🇺🇸 Allentown, Pennsylvania, United States

Acadiana Renal Physicians; 🇺🇸 New Iberia, Louisiana, United States

UNC Kidney Center; 🇺🇸 Chapel Hill, North Carolina, United States

Texas Transplant Physician'S Group; 🇺🇸 San Antonio, Texas, United States