Treatment of Antibody-Mediated Rejection (ABMR) With CarBel (NCT06918990) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
United States25 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Able to understand and agree to participate in the study.
✓. Have received a kidney transplant from a living or deceased donor (including re-transplants).
✓. Men and women must agree to use birth control during the study and for 3 months after the last dose of study drugs, or be surgically sterile or post-menopausal.
✓. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.
✓. Must have been previously exposed to the Epstein-Barr Virus (EBV).
✓. Diagnosed with specific types of kidney transplant rejection based on criteria, with certain conditions on timing and treatment history.
✓. Kidney function must be at a certain level (eGFR of at least 30 ml/min/1.73 m²).
✓. Specific scores related to kidney biopsy results must be within certain limits.
Exclusion criteria
✕
What they're measuring
1
Part A: Incidence of reduction in Microvascular Inflammation (MVI) >=2 points
Timeframe: 3-months post randomization and 12-months post receipt of Investigational Therapy (IT)
2
Part A: Incidence of reduction in the immunodominant donor-specific antibody (DSA) Mean Fluorescent Intensity (MFI) by >= 50%
Timeframe: 3-months post randomization and 12-months post receipt of IT
3
Part B: The incidence of 20% improvement in estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI 2021) slope
Timeframe: 3-months post randomization and 12-months post receipt IT
Trial details
NCT IDNCT06918990
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)