belatacept
belatacept: sourced relationships with 1 company · 6 clinical trials tracked · 1 FDA decision.
belatacept evidence translation
What we can confirm
1 FDA record · 6 tracked trials
What it means
What to watch
Prepared research question
How could belatacept → BMY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (3)
| Company | Dated record stage |
|---|---|
| BRISTOL MYERS SQUIBB CO (BMY) Reported 2011-06-15 · Current development: unknownSource Renal Allograft Recipients | Phase 3 |
| BRISTOL MYERS SQUIBB CO (BMY) Reported 2011-06-15 · Current development: unknownSource | Approved |
| BRISTOL MYERS SQUIBB CO (BMY) Reported 2011-06-15 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (6)
Measuring the Impact of Carfilzomib and Belatacept on Allogeneic Desensitization in Prospective Kidney Transplant Recipients (ITN089ST)
Primary endpoint: Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through 26 weeks (Cohort 1) after starting treatment or until receiving a transplant, whichever occurs earlier.
A Mechanistically Driven Therapy to Desensitize >98.0% cPRA Patients: Depletion of Plasma Cells With Anti-CD38 and Prevention of B Cell Activation With Costimulation Blockade (ITN090ST)
Primary endpoint: Proportion of subjects who have not met a subject stopping rule and remain free of all of the safety events listed in the outcome description, through 26 weeks after starting treatment or until receiving a transplant, whichever occurs earlier
A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
Primary endpoint: Proportion of participants who survive with a functional graft with estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (updated Schwartz formula) at 24 months post-randomization
Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)
Primary endpoint: The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 6 Months Post-transplantation.
Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)
Primary endpoint: Proportion of Participants who Achieve Operational Tolerance
Optimization of NULOJIX® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (CTOT-15)
Primary endpoint: Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with belatacept?
belatacept has dated SEC/FDA relationship records for BRISTOL MYERS SQUIBB CO.
How many clinical trials involve belatacept?
BioSniper tracks 6 clinical trials involving belatacept.
What is belatacept's latest FDA decision?
The most recent tracked FDA decision for belatacept is Approval for 1 INDICATIONS AND USAGE • NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. (1.1) Limitations of Use : • Use only in patients who are EBV seropositive. (1.2 , 4 , 5.1) • Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. (1.2 , 5.6) 1.1 Adult Kidney Transplant Recipients NULOJIX ® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. 1.2 Limitations of Use Use NULOJIX only in patients who are EBV seropositive [see Contraindications (4) and Warnings and Precautions (5.1) ] . Use of NULOJIX for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established [see Warnings and Precautions (5.6) ] ., dated June 15, 2011.