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Belatacept

Generic Name
Belatacept
Brand Names
Nulojix
Drug Type
Biotech
CAS Number
706808-37-9
Unique Ingredient Identifier
E3B2GI648A
Background

Belatacept is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Structurally, abatacept is a glycosylated fusion protein with a MALDI-MS molecular weight of 92,300 Da and it is a homodimer of two homologous polypeptide chains of 357 amino acids each. It is produced through recombinant DNA technology in mammalian CHO cells. The drug has activity as a selective co-stimulation modulator with inhibitory activity on T lymphocytes. It is approved for the treatment of rheumatoid arthritis. Belatacept selectively blocks the process of T-cell activation. It was developed by Bristol-Myers-Squibb. Belatacept is only 2 amino acids different from abatacept (Orencia). FDA approved on June 15, 2011.

Indication

For prophylaxis of organ rejection. It is also used concomitantly with basiliximumab for induction therapy, mycophenolate, and corticosteriods in kidney transplant recepients that are seropositive for the Epstein-Barr virus.

Associated Conditions
Kidney Transplant Rejection

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

Phase 3
Completed
Conditions
Chronic Kidney Failure
Kidney Transplantation
Interventions
First Posted Date
2005-11-22
Last Posted Date
2016-08-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
738
Registration Number
NCT00256750
Locations
🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

🇺🇸

Medical College Of Georgia, Augusta, Georgia, United States

and more 32 locations

Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

First Posted Date
2005-06-20
Last Posted Date
2017-07-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
595
Registration Number
NCT00114777
Locations
🇺🇸

Sharp Memorial Hospital, San Diego, California, United States

🇺🇸

University Of Alabama At Birmingham, Birmingham, Alabama, United States

🇺🇸

National Institute Of Transplantation, Los Angeles, California, United States

and more 26 locations

Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

Phase 2
Completed
Conditions
Graft Rejection
Kidney Transplantation
Renal Transplantation
Interventions
First Posted Date
2002-05-06
Last Posted Date
2014-01-13
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
230
Registration Number
NCT00035555
Locations
🇺🇸

Medical Univ. of South Carolina, Charleston, South Carolina, United States

🇺🇸

Univ. of Nebraska Medical Center, Omaha, Nebraska, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 9 locations
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