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

Clinical Trials

Abatacept Conversion in Kidney Transplantation

Phase 2

Active, not recruiting

Conditions: Renal Transplant Recipient

Interventions: Drug: Belatacept
Drug: Abatacept

First Posted Date: 2021-07-08

Last Posted Date: 2024-09-27

Lead Sponsor: Emory University

Target Recruit Count: 86

Registration Number: NCT04955366

Locations: 🇺🇸
Emory University Hospital (EUH), Atlanta, Georgia, United States

A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

Phase 3

Recruiting

Conditions: Renal Allograft Recipients

Interventions: Biological: Belatacept
Drug: Tacrolimus
Drug: Cyclosporine A
Drug: Mycophenolate Mofetil
Drug: Enteric Coated Mycophenolate Sodium
Drug: Corticosteroids

First Posted Date: 2021-05-07

Last Posted Date: 2025-04-08

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 102

Registration Number: NCT04877288

Locations: 🇺🇸
Local Institution - 0022, Hollywood, Florida, United States
🇺🇸
Local Institution - 0045, Miami, Florida, United States
🇺🇸
Local Institution - 0049, Atlanta, Georgia, United States

and more 34 locations

Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

Phase 4

Conditions: Kidney Transplant Rejection

Interventions: Drug: Belatacept
Drug: Everolimus
Drug: mycophenolate mofetil
Drug: corticosteroids
Drug: rabbit antithymocyte globulin

First Posted Date: 2021-04-19

Last Posted Date: 2021-04-19

Lead Sponsor: University of Cincinnati

Target Recruit Count: 120

Registration Number: NCT04849533

Locations: 🇺🇸
The Christ Hospital, Cincinnati, Ohio, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

Daratumumab and Belatacept for Desensitization

Phase 1

Recruiting

Conditions: Highly Sensitized Prospective Kidney Transplant Recipients

Interventions: Biological: daratumumab
Biological: belatacept
Procedure: Bone marrow aspiration

First Posted Date: 2021-04-01

Last Posted Date: 2025-02-24

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 15

Registration Number: NCT04827979

Locations: 🇺🇸
University of California at San Francisco Medical Center, San Francisco, California, United States

Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

Phase 4

Recruiting

Conditions: Kidney Transplant Immunosuppression

Interventions: Drug: Belatacept

First Posted Date: 2021-03-08

Last Posted Date: 2025-03-06

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 25

Registration Number: NCT04786067

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Recruiting

Conditions: Kidney Transplant Rejection

Interventions: Drug: Belatacept Injection [Nulojix]

First Posted Date: 2021-02-03

Last Posted Date: 2025-04-10

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 70

Registration Number: NCT04736381

Locations: 🇫🇷
Nephrologie transplantation CHRU Besançon, Besançon, France
🇫🇷
Néphrologie, hémodialyse, aphérèses, transplantation rénale, La Tronche, France
🇫🇷
Nephrologie transplantation CHRU Nantes, Nantes, France

and more 6 locations

Belatacept in De Novo Heart Transplantation

Phase 2

Recruiting

Conditions: Heart Transplantation

Interventions: Drug: Belatacept
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Drug: Corticosteroid

First Posted Date: 2020-07-20

Last Posted Date: 2025-01-22

Lead Sponsor: NYU Langone Health

Target Recruit Count: 12

Registration Number: NCT04477629

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States
🇺🇸
Columbia University, New York, New York, United States

Pilot Study: Interest of Belatacept As a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients At Risk of Chronic Renal Failure (BELACOEUR)

Phase 2

Recruiting

Conditions: Heart Transplant Failure

Interventions: Drug: Belatacept Injection

First Posted Date: 2019-11-27

Last Posted Date: 2024-11-28

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 25

Registration Number: NCT04180085

Locations: 🇫🇷
Karine Nubret, Bordeaux, France
🇫🇷
Bertrand Lelong, Rennes, France
🇫🇷
Claire Garandeau, Nantes, France

and more 1 locations

Treg Modulation With CD28 and IL-6 Receptor Antagonists

Phase 1

Completed

Conditions: Living-Donor Kidney Transplant
Kidney Transplant Recipients

Interventions: Biological: lulizumab pegol
Biological: antithymocyte globulin (rabbit)
Drug: methylprednisolone
Biological: tocilizumab
Drug: Prednisone
Drug: everolimus
Biological: belatacept
Drug: mycophenolate mofetil
Drug: mycophenolic acid

First Posted Date: 2019-08-26

Last Posted Date: 2024-10-09

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 24

Registration Number: NCT04066114

Locations: 🇺🇸
Cleveland Clinic Foundation: Transplantation, Cleveland, Ohio, United States
🇺🇸
University of California San Francisco School of Medicine: Transplantation, San Francisco, California, United States
🇺🇸
University of Alabama School of Medicine: Transplantation, Birmingham, Alabama, United States

and more 4 locations

A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant

Phase 2

Completed

Conditions: Allografts
Rejection; Transplant, Kidney
Transplant Rejection
Kidney Transplantation

Interventions: Drug: Belatacept
Drug: VIB4920
Drug: Thymoglobulin
Drug: Methylprednisolone

First Posted Date: 2019-08-06

Last Posted Date: 2024-12-27

Lead Sponsor: Amgen

Target Recruit Count: 25

Registration Number: NCT04046549

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Keck Medical Center of USC, Los Angeles, California, United States
🇺🇸
Duke University School of Medicine, Durham, North Carolina, United States

and more 1 locations

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