drugset / Trial / NCT06918990
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of carfilzomib and belatacept, administered with steroids and maintenance immunosuppression, in kidney transplant recipients with donor-specific antibody (DSA)-associated graft injury. Participants will be followed for 52 weeks after starting investigational therapy, including protocol biopsies at 3 months and 12 months after start of investigational therapy. The study will also assess changes in immune cell responses, blood and urine biomarkers, and biopsy-based pathomic features associated with antibody-mediated graft injury.
Timeline
- Start
- 2026-05-29
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | — | Intravenous |
| Subject | Carfilzomib | Other / unclassified | — | Intravenous |