Actively Recruiting
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-11
25
Participants Needed
10
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy 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.
CONDITIONS
Official Title
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 last dose, or be surgically sterile or post-menopausal.
- Heart function must be good enough (LVEF of at least 40%) without severe heart issues or pulmonary hypertension.
- Must have been previously exposed to Epstein-Barr Virus (EBV).
- Diagnosed with specific types of kidney transplant rejection based on criteria, with conditions on timing and treatment history.
- Kidney function must be at least 30 ml/min/1.73 m² eGFR.
- Specific kidney biopsy scores must be within certain limits.
- At least 6 months post-transplant or less than 6 months with documentation of prior standard care treatment.
- Must have measurable donor-specific antibodies (HLA DSA) with defined intensity.
- Up-to-date vaccinations per transplant guidelines.
- Negative tuberculosis test and chest x-ray, no symptoms or contact with TB, no recent travel to high TB areas; previous TB infection must be treated and have recent negative chest x-ray.
- If previously infected with COVID-19, must be fully recovered for at least 21 days before joining.
You will not qualify if you...
- Unable or unwilling to give consent or follow study rules.
- Kidney transplant with incompatible blood types.
- Very high protein levels in urine indicating severe kidney issues.
- Previous non-kidney organ or bone marrow transplant.
- Other medical issues increasing risk or affecting study per doctor judgment.
- Heart attack within last year, uncontrolled chest pain, or recent heart problem on ECG.
- Severe heart failure (Class 3 or higher).
- Irregular heartbeats not controlled by medication.
- Recent or ongoing treatment with certain immunotherapies without required washout periods.
- Use of experimental drugs within 4 weeks or longer if drug remains in body.
- Serious medical or mental health issues interfering with study.
- Cancer diagnosis or treatment within past 2 years except certain skin cancers or highly curable cancers.
- Allergy to Captisol®.
- Very low blood counts (hemoglobin, neutrophils, platelets).
- Positive for HIV, Hepatitis B, or C unless Hepatitis C successfully treated.
- Severe infections needing treatment in last 4 weeks.
- Specific kidney infections or high BK virus levels.
- Kidney biopsy results showing other rejection types or diseases.
- Recent treatment or resistance to CMV therapies.
- Received live vaccine in last 4 weeks.
- Severe liver disease or abnormal liver tests.
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test.
- Other significant medical conditions affecting study as per doctor.
- Recent antibody treatments within 3 months.
- Kidney rejection within 6 months post-transplant without standard care.
- History of multiple unprovoked blood clots.
- Diagnosed with Atypical Hemolytic Uremic Syndrome (aHUS).
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
3
UCLA Medical Center (Site #: 71123)
Los Angeles, California, United States, 90024
Not Yet Recruiting
4
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Not Yet Recruiting
5
Washington University
St Louis, Missouri, United States, 63110
Not Yet Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
Duke University
Durham, North Carolina, United States, 27710
Not Yet Recruiting
8
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
10
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53726
Not Yet Recruiting
Research Team
Y
Yvonne Morrison, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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