A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00719225
First received: July 17, 2008
Last updated: July 13, 2011
Last verified: July 2011
  Purpose

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

Condition Intervention
Renal Transplantation
Drug: Belatacept

Study Type: Expanded Access     What is Expanded Access?
Official Title: Belatacept for Renal Allograft Recipients: A Compassionate Use Program

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Intervention Details:
    Drug: Belatacept
    IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially
    Other Names:
    • LEA29Y
    • BMS-224818
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719225

Locations
United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Georgia
Office Of Dr. Allan Kirk
Atlanta, Georgia, United States, 30322
United States, Louisiana
Local Institution
New Iberia, Louisiana, United States, 70563
Tulane Abdominal Transplant
New Orleans, Louisiana, United States, 70112
United States, Pennsylvania
The Transplant Center Of The Lehigh Valley
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00719225     History of Changes
Other Study ID Numbers: IM103-056
Study First Received: July 17, 2008
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014