A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Bristol-Myers Squibb (BMS)

Status

Conditions: Renal Transplantation

Treatments: Drug: Belatacept

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00719225

IM103-056

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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