A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 non-renal 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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

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