Treatment of Antibody-Mediated Rejection (ABMR) With CarBel
CarBel
Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)
1 other identifier
interventional
25
1 country
9
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2026
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 10, 2026
March 1, 2026
1.2 years
April 2, 2025
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part A: Incidence of reduction in Microvascular Inflammation (MVI) >=2 points
3-months post randomization and 12-months post receipt of Investigational Therapy (IT)
Part A: Incidence of reduction in the immunodominant donor-specific antibody (DSA) Mean Fluorescent Intensity (MFI) by >= 50%
3-months post randomization and 12-months post receipt of IT
Part B: The incidence of 20% improvement in estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI 2021) slope
3-months post randomization and 12-months post receipt IT
Secondary Outcomes (15)
Change in albuminuria
3-months post randomization and 12-months post receipt of IT
Change in Banff lesion grading score (2022 criteria)
3-months post randomization and 12-months post receipt of IT
Change in immunodominant donor-specific antibody (DSA) MFI
3-months post randomization and 12-months post receipt of IT
Change in estimated Glomerular Filtration Rate (eGFR) (2022 criteria)
3-months post randomization and 12-months post receipt of IT
Incidence of Antibody-Mediated Rejection (ABMR)
3-months post randomization and 12-months post receipt of IT
- +10 more secondary outcomes
Study Arms (2)
Investigational Treatment Arm
EXPERIMENTALStudy Entry to Month-3 participants will receive: * Steroid pulse/taper * Kyprolis® (Carfilzomib) * Nulojix® (Belatacept) * Tacrolimus * Mycophenolate * Prednisone After 3 months participants will receive: * Belatacept + * Mycophenolate * Prednisone * Tacrolimus
Conventional Treatment Arm
EXPERIMENTALStudy Entry to Month-3 participants will receive: * Steroid pulse/taper * Intravenous Immunoglobulin (IVIG) * Tacrolimus OR Belatacept + * Mycophenolate * Prednisone After 3 months participants will receive: * Kyprolis® (Carfilzomib) * Nulojix ® (Belatacept) * Tacrolimus * Mycophenolate * Prednisone After an additional 3 months (6 months from study entry) participants will receive: * Belatacept + * Mycophenolate * Prednisone * Tacrolimus
Interventions
Administered by intravenous infusion over 60 minutes.
Administered by intravenous infusion over 30 minutes.
Eligibility Criteria
You may qualify if:
- 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.
- Must have a measurable level of specific antibodies against the donor kidney (HLA DSA) with a certain intensity.
- Up-to-date vaccinations according to guidelines for transplant patients.
- Must have a negative tuberculosis (TB) test and chest x-ray before enrollment, no symptoms or known contact with TB, and not have recently traveled to or lived in areas with high TB rates. If previously infected with TB, must have completed treatment and have a recent negative chest x-ray.
- If previously infected with COVID-19, must be fully recovered for at least 21 days before joining the study. No COVID-19 test required for those without symptoms.
You may not qualify if:
- Unable or unwilling to give consent or follow study rules.
- Kidney transplant with incompatible blood types.
- Very high levels of protein in urine, indicating severe kidney issues.
- Previously had a non-kidney organ or bone marrow transplant.
- Any other medical issues that might increase risk, make following the study rules hard, or affect study results, as judged by the study doctor.
- Heart attack within the last year, uncontrolled chest pain, or signs of a recent heart problem on an ECG.
- Severe heart failure (Class 3 or higher).
- Irregular heartbeats that can't be controlled with medication.
- Used any experimental drug within the last 4 weeks or longer if the drug stays in the body longer.
- Serious medical or mental health issues that could interfere with the study.
- Cancer diagnosis or treatment within the past 2 years, except for certain skin cancers or cancers with a high cure rate.
- Known allergy to Captisol® (used in the study drug).
- Very low blood counts (hemoglobin, neutrophils, or platelets).
- Positive for HIV, Hepatitis B, or Hepatitis C, unless Hepatitis C was successfully treated.
- Severe infections needing treatment in the last 4 weeks.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Alabama Medical Center
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Washington University
St Louis, Missouri, 63110, United States
NYU Langone Health
New York, New York, 10016, United States
Duke University
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53726, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart J Knechtle, M.D.
Duke University Medical Center: Transplantation
- STUDY CHAIR
Scott Sanoff, MD, Ph.D.
Duke University Medical Center: Transplantation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2025
First Posted
April 9, 2025
Study Start
April 15, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 10, 2026
Record last verified: 2026-03