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NOT YET RECRUITING
NCT06918990
PHASE2

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

The purpose of this study is to see: 1. If using these two drugs (carfilzomib and belatacept) together is safe 2. If the use of these two study drugs in addition to the usual immunosuppression for kidney transplant patients can improve your transplanted kidney function by lowering the antibodies you have against your transplanted kidney 3. If the study drugs effect the immune cells that were responding to your donor kidney. And, whether blood or urine tests can measure signs of inflammation and kidney cell injury 4. If using new computer techniques can help describe important changes seen on biopsy in your donated kidneys The primary objective is to assess the efficacy of carfilzomib and belatacept therapy when added to current treatment with steroids and maintenance immunosuppression, compared to conventional treatment alone, to improve the clinical outcome in renal transplant patients with donor-specific antibody (DSA) and associated graft injury occurring more than 6 months after renal transplantation or less than 6 months post-transplant.

Official title: Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-04-15

Completion Date

2027-06-30

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Carfilzomib

Administered by intravenous infusion over 60 minutes.

BIOLOGICAL

Belatacept

Administered by intravenous infusion over 30 minutes.

Locations (9)

University of Alabama Medical Center

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Washington University

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States