RECRUITING

Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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 of renal transplant patients with active and chronic - active ABMR occurring more than 6 months after renal transplantation or less than 6 months post-transplant with persistent refractory Antibody-Mediated Rejection (ABMR)

Official Title

Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)

Quick Facts

Study Start:2025-07-31
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06918990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to understand and agree to participate in the study.
  2. 2. Have received a kidney transplant from a living or deceased donor (including re-transplants).
  3. 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. 4. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.
  5. 5. Must have been previously exposed to the Epstein-Barr Virus (EBV).
  6. 6. Diagnosed with specific types of kidney transplant rejection based on criteria, with certain conditions on timing and treatment history.
  7. 7. Kidney function must be at a certain level (eGFR of at least 30 ml/min/1.73 m²).
  8. 8. Specific scores related to kidney biopsy results must be within certain limits.
  9. 9. Must have a measurable level of specific antibodies against the donor kidney (HLA DSA) with a certain intensity.
  10. 10. Up-to-date vaccinations according to guidelines for transplant patients.
  11. 11. 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.
  12. 12. 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.
  1. 1. Unable or unwilling to give consent or follow study rules.
  2. 2. Kidney transplant with incompatible blood types.
  3. 3. Very high levels of protein in urine, indicating severe kidney issues.
  4. 4. Previously had a non-kidney organ or bone marrow transplant.
  5. 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. 6. Heart attack within the last year, uncontrolled chest pain, or signs of a recent heart problem on an ECG.
  7. 7. Severe heart failure (Class 3 or higher).
  8. 8. Irregular heartbeats that can't be controlled with medication.
  9. 9. Used any experimental drug within the last 4 weeks or longer if the drug stays in the body longer.
  10. 10. Serious medical or mental health issues that could interfere with the study.
  11. 11. Cancer diagnosis or treatment within the past 2 years, except for certain skin cancers or cancers with a high cure rate.
  12. 12. Known allergy to Captisol® (used in the study drug).
  13. 13. Very low blood counts (hemoglobin, neutrophils, or platelets).
  14. 14. Positive for HIV, Hepatitis B, or Hepatitis C, unless Hepatitis C was successfully treated.
  15. 15. Severe infections needing treatment in the last 4 weeks.
  16. 16. Specific kidney infection (BK nephropathy) or high levels of BK virus.
  17. 17. Certain kidney biopsy results indicating other types of rejection or kidney diseases.
  18. 18. Treated for a specific viral infection (CMV) in the last 90 days or resistant to certain CMV treatments.
  19. 19. Received a live vaccine in the last 4 weeks.
  20. 20. Severe liver disease or abnormal liver tests.
  21. 21. Pregnant or breastfeeding women. Women who can become pregnant must have a negative pregnancy test or proof they are not pregnant.
  22. 22. Any other significant medical condition that could interfere with the study according to the doctor.
  23. 23. Received certain antibody treatments in the last 3 months.
  24. 24. Kidney rejection within 6 months post-transplant without standard care.
  25. 25. Confirmed severe protein levels in urine.
  26. 26. Underwent certain treatments outside study criteria.
  27. 27. History of multiple unprovoked blood clots.
  28. 28. Diagnosed with Atypical Hemolytic Uremic Syndrome (aHUS).

Contacts and Locations

Study Contact

Yvonne Morrison, MS
CONTACT
301-706-9137
ymorrison@niaid.nih.gov

Principal Investigator

Stuart J Knechtle, M.D.
PRINCIPAL_INVESTIGATOR
Duke University Medical Center: Transplantation
Scott Sanoff, MD, Ph.D.
STUDY_CHAIR
Duke University Medical Center: Transplantation

Study Locations (Sites)

Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Washington University
Saint Louis, Missouri, 63108
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

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Stuart J Knechtle, M.D., PRINCIPAL_INVESTIGATOR, Duke University Medical Center: Transplantation
  • Scott Sanoff, MD, Ph.D., STUDY_CHAIR, Duke University Medical Center: Transplantation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-31
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-07-31
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Carfilzomib
  • Kidney transplant
  • Belatacept

Additional Relevant MeSH Terms

  • Kidney Transplant Rejection