drugset / Trial / NCT06918990

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

NCT06918990

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

EvaluationDrugModalityDoseRoute
Subject Belatacept Protein / enzyme biologic Intravenous
Subject Carfilzomib Other / unclassified Intravenous

Indications