Belatacept

Generic Name: Belatacept

Brand Names: Nulojix

Drug Type: Biotech

Chemical Formula: -

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 t...

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

Associated Therapies: -

Clinical Trials

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Phase 2

Recruiting

Conditions: Immunosuppression

Interventions: Drug: Belatacept
Procedure: Hand transplant

First Posted Date: 2014-12-08

Last Posted Date: 2024-01-29

Lead Sponsor: Linda Cendales

Target Recruit Count: 50

Registration Number: NCT02310867

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Belatacept 3 Month Post Transplant Conversion Study

Phase 4

Completed

Conditions: EBV
Transplant; Failure, Kidney

Interventions: Drug: belatacept
Drug: MPA
Drug: Tacrolimus

First Posted Date: 2014-08-11

Last Posted Date: 2023-02-08

Lead Sponsor: Lorenzo Gallon

Target Recruit Count: 28

Registration Number: NCT02213068

Locations: 🇺🇸
Northwestern University, The Comprehensive Transplant Center, Chicago, Illinois, United States

Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Phase 4

Completed

Conditions: Implant or Graft; Rejection

Interventions: Drug: Belatacept
Drug: Tacrolimus
Drug: Mycophenolate
Drug: rATG
Drug: Methylprednisolone
Procedure: Renal transplant

First Posted Date: 2014-06-02

Last Posted Date: 2021-02-10

Lead Sponsor: Columbia University

Target Recruit Count: 57

Registration Number: NCT02152345

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States

Regimen Optimization Study

Phase 2

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Thymoglobulin
Drug: mycophenolate mofetil(MMF)
Drug: Belatacept
Drug: Corticosteroids
Drug: Everolimus(EVL)
Drug: Tacrolimus(TAC)

First Posted Date: 2014-05-13

Last Posted Date: 2021-06-22

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 58

Registration Number: NCT02137239

Locations: 🇺🇸
Emory Univeristy, Atlanta, Georgia, United States
🇺🇸
University Of Illinois, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 17 locations

Belatacept for Renal Transplant Recipients With Delayed Graft Function

Early Phase 1

Terminated

Conditions: Delayed Graft Function

Interventions: Drug: Everolimus
Drug: Belatacept

First Posted Date: 2014-05-09

Last Posted Date: 2021-09-23

Lead Sponsor: Ohio State University

Target Recruit Count: 8

Registration Number: NCT02134288

Locations: 🇺🇸
The Ohio State Universtiy Wexner Medical Center, Columbus, Ohio, United States

Belatacept in Kidney Transplantation of Moderately Sensitized Patients

Phase 4

Withdrawn

Conditions: End Stage Renal Disease
Antibody Mediated Rejection

Interventions: Drug: Belatacept
Drug: Tacrolimus withdrawal
Procedure: Plasmapheresis/Intravenous Immunoglobulin G
Drug: Thymoglobulin (ATG)
Drug: Myfortic
Drug: Steroids

First Posted Date: 2014-05-05

Last Posted Date: 2018-12-17

Lead Sponsor: University of Wisconsin, Madison

Registration Number: NCT02130817

Locations: 🇺🇸
University of Wiscsonsin Hospital and Clinics, Madison, Wisconsin, United States

Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

Phase 4

Completed

Conditions: Nephrotoxicity

Interventions: Drug: Belatacept

First Posted Date: 2014-04-04

Last Posted Date: 2017-08-28

Lead Sponsor: Indiana University

Target Recruit Count: 6

Registration Number: NCT02103855

Locations: 🇺🇸
Indiana University Health, University Hospital, Indianapolis, Indiana, United States

Efficacy of Belatacept in Reducing DSA

Phase 4

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Belatacept

First Posted Date: 2014-03-05

Last Posted Date: 2017-08-01

Lead Sponsor: East Carolina University

Target Recruit Count: 3

Registration Number: NCT02078193

Locations: 🇺🇸
East Carolina University, Greenville, North Carolina, United States

Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)

Phase 4

Completed

Conditions: Renal Transplant Rejection

Interventions: Drug: Belatacept

First Posted Date: 2013-09-30

Last Posted Date: 2022-12-13

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 20

Registration Number: NCT01953120

Locations: 🇺🇸
UCLA Kidney Transplant Research, Los Angeles, California, United States

Belatacept Therapy for the Failing Renal Allograft

Phase 3

Completed

Conditions: Failing Renal Allograft

Interventions: Drug: Calcineurin inhibitor therapy
Drug: Belatacept
Drug: Mycophenolate mofetil
Drug: prednisone

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

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