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Belatacept · 1 trial · 4 indications
Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima.
| Arm | Type | Description |
|---|---|---|
| Belatacept+VIB4920 | EXPERIMENTAL | Participants will be admitted to the transplant center for the administration of VIB4920 and belatacept (with Thymoglobulin and corticosteroids) and will be discharged on Day 3/4 at the discretion of the investigator. Participants will return to the study center to receive study drugs (VIB4920 and /or belatacept) weekly for 2 visits, then every 2 weeks for 5 visits, and then monthly for 9 visits for safety monitoring. |
| Name | Type | Description |
|---|---|---|
| Belatacept | DRUG | Protocol versions 1 through 4: Belatacept 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), and at the end of Weeks 2, 4, 8 and 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48. |
| VIB4920 | DRUG | Protocol versions 1 and 2: VIB4920 1500 mg by IV infusion on post-op Days 1 and 14, and at the end of Weeks 4, 6, 8 and 10; then 1500 mg every 4 weeks from Week 12 to Week 48. Protocol versions 3 and 4: VIB4920 1500 mg by IV infusion on post-op Days 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), Week 2, and at the end of Weeks 4, 6, 8, and 10; then 1500 mg every 4 weeks from Week 12 to Week 48. |
| Thymoglobulin | DRUG | Protocol versions 1 and 2: Thymoglobulin 3.0 mg/kg by intravenous (IV) infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0) (1 dose). Protocol versions 3 and 4: Thymoglobulin 1.5 mg/kg by intravenous infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4. |
| Methylprednisolone | DRUG | Protocol versions 1 and 2: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, and 6. Protocol versions 3 and 4: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to at least 20 mg per day on Day 8, to at least 10 mg per day on Day 15, and to at least 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit. |
Inclusion Criteria: * Recipients of a first renal transplant from standard criteria deceased, living unrelated or HLA non-identical living related donor. * Recipients who are at low immunologic risk: 1. No donor specific antibodies (DSA), and 2. Negative cross-match testing. * Recipients with ...
Belatacept is used for prophylaxis of allograft rejection in adults receiving a kidney transplant. It is being studied in the context of allografts, specifically to prevent transplant rejection. The drug is currently in Phase 2 clinical development and is being developed by Amgen Inc.
Belatacept is a small molecule that targets costimulation pathways involved in T-cell activation. It works by blocking dual costimulation, which is essential for the immune response that leads to allograft rejection. This mechanism helps prevent the rejection of transplanted organs, particularly in kidney transplant recipients.
Belatacept is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of Belatacept for the prophylaxis of allograft rejection in kidney transplant patients.
Belatacept is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and efficacy in preventing allograft rejection in adults receiving a kidney transplant, with one completed Phase 2 trial.
Belatacept has been evaluated in one clinical trial with the identifier NCT04046549. This Phase 2 study, titled "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," was completed in the United States with 25 participants.
No, Belatacept is not the same as VIB4920. In the clinical trial NCT04046549, Belatacept was studied in combination with VIB4920 as a dual costimulation blockade approach. Belatacept is the drug of interest, while VIB4920 is a separate investigational agent used alongside it in the study.