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Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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
Conditions
Interventions
Carfilzomib
Administered by intravenous infusion over 60 minutes.
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