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 Therapy for the Failing Renal Allograft
- Conditions
- Failing Renal Allograft
- Interventions
- First Posted Date
- 2013-08-13
- Last Posted Date
- 2021-01-26
- Lead Sponsor
- Andrew B Adams
- Target Recruit Count
- 13
- Registration Number
- NCT01921218
- Locations
- 🇺🇸
Emory University, Atlanta, Georgia, United States
Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression
- Conditions
- New Onset Diabetes After TransplantKidney Transplantation
- Interventions
- First Posted Date
- 2013-06-11
- Last Posted Date
- 2013-06-11
- Lead Sponsor
- University of Arizona
- Target Recruit Count
- 32
- Registration Number
- NCT01875224
- Locations
- 🇺🇸
University of Arizona, Tucson, Arizona, United States
Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function
- Conditions
- Delayed Graft FunctionKidney Transplant
- Interventions
- Drug: Calcineurin Inhibitor
- First Posted Date
- 2013-04-22
- Last Posted Date
- 2017-01-30
- Lead Sponsor
- Nair, Vinay, D.O.
- Target Recruit Count
- 90
- Registration Number
- NCT01837043
- Locations
- 🇺🇸
Mount Sinai School of Medicine Recanati/Miller Transplantation Institute, New York, New York, United States
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
- Conditions
- Kidney Transplantation
- Interventions
- First Posted Date
- 2013-03-29
- Last Posted Date
- 2021-01-05
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 446
- Registration Number
- NCT01820572
- Locations
- 🇺🇸
Transplant Research Institute (PI Address), Los Angeles, California, United States
🇺🇸Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸Saint Barnabas Medical Center, Livingston, New Jersey, United States
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
- First Posted Date
- 2013-02-15
- Last Posted Date
- 2017-07-24
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 16
- Registration Number
- NCT01791491
- Locations
- 🇺🇸
Boston Childrens Hospital, Boston, Massachusetts, United States
🇺🇸University Of Alabama At Birmingham, Birmingham, Alabama, United States
🇺🇸Childrens Hospital Of La, Los Angeles, California, United States
Belatacept Early Steroid Withdrawal Trial
- Conditions
- Renal Transplantation
- Interventions
- Drug: early cessation of steroids
- First Posted Date
- 2012-11-20
- Last Posted Date
- 2021-07-28
- Lead Sponsor
- University of Cincinnati
- Target Recruit Count
- 316
- Registration Number
- NCT01729494
- Locations
- 🇺🇸
University of Wisconsin-Madison, Madison, Wisconsin, United States
🇺🇸Tampa General Hospital, Tampa, Florida, United States
🇺🇸The Christ Hospital, Cincinnati, Ohio, United States
Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients
- Conditions
- Kidney TransplantationTransplantation, Kidney
- Interventions
- Drug: Calcineurin inhibitors (CNI)
- First Posted Date
- 2012-08-03
- Last Posted Date
- 2022-07-22
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 775
- Registration Number
- NCT01656343
Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores
- First Posted Date
- 2011-12-21
- Last Posted Date
- 2018-06-14
- Lead Sponsor
- University of Maryland
- Target Recruit Count
- 20
- Registration Number
- NCT01496417
- Locations
- 🇺🇸
University of Maryland, Baltimore, Maryland, United States
Calcineurin Inhibitor-free, Steroid-free Immunosuppressive Regimen in Simultaneous Islet-Kidney Transplantation for Uremic Type 1 Diabetic Patients
- Conditions
- Islets of Langerhans TransplantationDiabetes Mellitus, Type 1Kidney Transplantation
- Interventions
- First Posted Date
- 2009-12-16
- Last Posted Date
- 2013-05-08
- Lead Sponsor
- University of Wisconsin, Madison
- Registration Number
- NCT01033500
- Locations
- 🇺🇸
University of Wisconsin, Madison, Wisconsin, United States
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
- Conditions
- Renal Transplantation
- First Posted Date
- 2008-07-21
- Last Posted Date
- 2021-11-23
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT00719225
- Locations
- 🇺🇸
Scripps Green Hospital, La Jolla, California, United States
🇺🇸Tulane Abdominal Transplant Institute, New Orleans, Louisiana, United States
🇺🇸Office Of Dr. Allan Kirk, Atlanta, Georgia, United States
Drug Development Updates
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