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Bristol-Myers Squibb

A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Official Title: 
Belatacept for Renal Allograft Recipients: A Compassionate Use Program
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 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
Approved for marketing
Renal Transplantation

Drug: Belatacept
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Other Name: LEA29Y
Other Name: BMS-224818

Eligibility 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

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 18 Years
Countries: 
United States
Locations: 

Scripps Green Hospital
La Jolla, California, 92037

Office Of Dr. Allan Kirk
Atlanta, Georgia, 30322

Local Institution
New Iberia, Louisiana, 70563

Tulane Abdominal Transplant
New Orleans, Louisiana, 70112

The Transplant Center Of The Lehigh Valley
Allentown, Pennsylvania, 18103

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Bristol-Myers Squibb
EA Number: 
MeSH Terms: 
Abatacept
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