A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Status:

NO_LONGER_AVAILABLE

A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Renal Transplantation

Eligibility:

All Genders

18+ years

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 ade...

Eligibility Criteria

Inclusion

Please call 800-398-9157 for information on this study
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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00719225

Last Update

November 23 2021

Active Locations (7)

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Page 1 of 2 (7 locations)

Scripps Green Hospital

La Jolla, California, United States, 92037

Office Of Dr. Allan Kirk

Atlanta, Georgia, United States, 30322

Acadiana Renal Physicians

New Iberia, Louisiana, United States, 70563