A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
NCT00719225 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2021-11-23
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 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
Conditions
- Renal Transplantation
Interventions
- DRUG
-
Belatacept
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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