Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Eligible age
18–75 yrs
Accepts
All genders
Locations
9 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may qualify if…
- ✓ 1. Able to understand and agree to participate in the study.
- ✓ 2. Have received a kidney transplant from a living or deceased donor (including re-transplants).
- ✓ 3. 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.
- ✓ 4. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.
- ✓ 5. Must have been previously exposed to the Epstein-Barr Virus (EBV).
- ✓ 6. Diagnosed with specific types of kidney transplant rejection based on criteria, with certain conditions on timing and treatment history.
- ✓ 7. Kidney function must be at a certain level (eGFR of at least 30 ml/min/1.73 m²).
- ✓ 8. Patient is ≥6-months post-transplant or is \<6 months post-transplant but has documentation that they have been offered and/or received the local standard of care treatment prior to enrollment.
You may not qualify if…
- ✕ 1. Unable or unwilling to give consent or follow study rules.
- ✕ 2. Kidney transplant with incompatible blood types.
- ✕ 3. Very high levels of protein in urine, indicating severe kidney issues.
- ✕ 4. Previously had a non-kidney organ or bone marrow transplant.
- ✕ 5. Any other medical issues that might increase risk, make following the study rules hard, or affect study results, as judged by the study doctor.
- ✕ 6. Heart attack within the last year, uncontrolled chest pain, or signs of a recent heart problem on an ECG.
- ✕ 7. Severe heart failure (Class 3 or higher).
- ✕ 8. Irregular heartbeats that can't be controlled with medication.
Where it's recruiting
Birmingham
Phoenix
Los Angeles
Chicago
St Louis
New York
Durham
Cincinnati · Cleveland
Madison
Source: ClinicalTrials.gov · NCT06918990 · last updated 2026-08-10