Treatment of Antibody-Mediated Rejection (ABMR) With CarBel (NCT06918990)

🧪 Interventions in This Study

• Carfilzomib (BIOLOGICAL)
• Belatacept (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.
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 to guidelines for transplant patients.
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. 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

• University of Alabama Medical Center (Site # 71136) — Birmingham, Alabama
• Mayo Clinic Arizona (Site # 71144) — Phoenix, Arizona
• UCLA Medical Center (Site #: 71123) — Los Angeles, California
• Northwestern University, Feinberg School of Medicine (Site # 71110) — Chicago, Illinois
• Washington University (Site # 71157) — St Louis, Missouri
• NYU Langone Health (Site # 71177) — New York, New York
• Duke University (Site # 71139) — Durham, North Carolina
• Christ Hospital (Site # 71195) — Cincinnati, Ohio
• University of Cincinnati (Site # 71118) — Cincinnati, Ohio
• Cleveland Clinic (Site # 71101) — Cleveland, Ohio
• University of Wisconsin Madison (Site # 71112) — Madison, Wisconsin

📞 Contact the Study Coordinator

Phone: (301) 706-9137

Email: ymorrison@niaid.nih.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Twenty-five participants will receive steroid pulse/taper, carfilzomib, belatacept, tacrolimus, mycophenolate, and prednisone according to protocol-defined dosing and maintenance immunosuppression.

More studies in Kidney Transplant Rejection

• Microbiome and Immunosuppression: The Mission Study — Minneapolis, Minnesota
• Trifecta-Kidney cfDNA-MMDx Study — Tampa, Florida
• Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection — Chicago, Illinois
• The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) — Birmingham, Alabama
• Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring — Los Angeles, California

Explore by condition: All Kidney Transplant Rejection clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.