Clinical Trial

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Study acronym: CarBel
Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the safety 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.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-08-11
critical Recruitment opened 2026-05-12
critical Phase changed: Phase 2 -> Phase 1 2026-05-12
critical Primary endpoint(s) modified 2026-05-12
minor Trial arms changed: 2 -> 1 2026-05-12
Trial Details
NCT Number NCT06918990
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Kidney Transplant Rejection
Enrollment 25 participants
Start Date 2026-05-27
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-10