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A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplantation

Intervention: Belatacept (Drug)

Phase: N/A

Status: Approved for marketing

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

Official title: Belatacept for Renal Allograft Recipients: A Compassionate Use Program

Study design: N/A

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Scripps Green Hospital, La Jolla, California 92037, United States

Office Of Dr. Allan Kirk, Atlanta, Georgia 30322, United States

Local Institution, New Iberia, Louisiana 70563, United States

Tulane Abdominal Transplant, New Orleans, Louisiana 70112, United States

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

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm


Last updated: July 13, 2011

Page last updated: August 23, 2015

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