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NCT00719225 Clinical Trial

A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00719225
Other study ID # IM103-056
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date November 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Belatacept
IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially

Locations
Country Name City State
United States The Transplant Center Of The Lehigh Valley Allentown Pennsylvania
United States Office Of Dr. Allan Kirk Atlanta Georgia
United States UNC Kidney Center Chapel Hill North Carolina
United States Scripps Green Hospital La Jolla California
United States Acadiana Renal Physicians New Iberia Louisiana
United States Tulane Abdominal Transplant Institute New Orleans Louisiana
United States Texas Transplant Physician'S Group San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

See also
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Recruiting NCT00903188 - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation Phase 4
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