NCT06918990 · National Institute of Allergy and Infectious Diseases (NIAID)
Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
(CarBel)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Carfilzomib
Administered by intravenous infusion over 60 minutes.
BIOLOGICAL
Belatacept
Administered by intravenous infusion over 30 minutes.
Primary outcome measures
Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following: Grade 3 or higher infusion reaction, Grade 3 or higher infections, and any malignancy excluding localized non-melanomatous skin cancer.
Time frame: 3-months post randomization and 12-months post receipt of Investigational Therapy (IT)
Proportion of subjects achieving either (1) ≥50% reduction in MFI or clearance below positivity threshold of immunodominant DSA, or (2) >20% improvement in 12-month post-treatment eGFR slope vs pre-enrollment
Time frame: 3-months post randomization and 12-months post receipt of IT
Mean fluorescent intensity (MFI), donor-specific antibody (DSA), and estimated glomerular filtration rate (eGFR). The endpoint is the proportion of subjects achieving either: 1. 50% reduction in mean fluorescent intensity (MFI) or elimination below threshold for positivity of the immunodominant donor-specific antibody (DSA), or 2. improvement in 12-month post-treatment estimated glomerular filtration rate (eGFR) slope of greater than 20% compared with pre-enrollment eGFR slope
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Specific scores related to kidney biopsy results must be within certain limits. 9. Must have a measurable level of specific antibodies against the donor kidney (HLA DSA) with a certain intensity. 10. Up-to-date vaccinations according
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Los Angeles, California
- Chicago, Illinois
- St Louis, Missouri
- New York, New York
- Durham, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations