Actively Recruiting
Safety Study of Carfilzomib and Belatacept for Treating Antibody-Mediated Kidney Transplant Rejection
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-08-10
25
Participants Needed
11
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of carfilzomib and belatacept, given with steroids and maintenance immunosuppression, in adults who have had a kidney transplant and are experiencing donor-specific antibody DSA-associated graft injury. This phase 1, open-label study aims to understand immune cell responses, blood and urine biomarkers, and biopsy features linked to antibody-mediated graft damage in this group. Participants will receive a combination of steroid pulsetaper, carfilzomib, belatacept, tacrolimus, mycophenolate, and prednisone for the first three months. After this, treatment continues with belatacept, mycophenolate, prednisone, and tacrolimus. Carfilzomib and belatacept are administered by intravenous infusion over 60 and 30 minutes, respectively. The study involves protocol kidney biopsies at three and twelve months post-treatment start. During the 12-month follow-up, participants will be monitored through regular assessments including biopsies, immune and biomarker testing, and safety checks. Researchers will measure outcomes such as safety events, kidney function, antibody levels, rejection episodes, and hospitalization days. Participants who stop treatment but agree to continue will remain in follow-up until study completion, lasting about one year from treatment start.
CONDITIONS
Brief Title
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Research Team
Y
Yvonne Morrison, MS
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