Carfilzomib + Belatacept for Kidney Transplant Rejection
(CarBel Trial)
Trial Summary
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications. However, it mentions that the study drugs are added to the usual immunosuppression treatment, suggesting you may continue your current medications.
What data supports the effectiveness of the drug Belatacept for kidney transplant rejection?
Is the combination of Carfilzomib and Belatacept safe for kidney transplant patients?
Belatacept is generally considered safe for kidney transplant patients, with some experiencing side effects like anemia, fever, and infections. It has a better cardiovascular and metabolic profile compared to other drugs, but there is a higher risk of certain diseases in patients without prior exposure to the Epstein-Barr virus.13567
How is the drug combination of Carfilzomib and Belatacept unique for treating kidney transplant rejection?
The combination of Carfilzomib and Belatacept is unique because Belatacept is a novel immunosuppressive drug that helps prevent organ rejection by blocking specific immune signals, potentially reducing the need for traditional drugs that can cause kidney damage. This approach aims to improve kidney function and reduce side effects compared to standard treatments.148910
What is the purpose of this trial?
The purpose of this study is to see:1. If using these two drugs (carfilzomib and belatacept) together is safe2. 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 kidney3. 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 injury4. If using new computer techniques can help describe important changes seen on biopsy in your donated kidneysThe 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)
Research Team
Stuart J Knechtle, M.D.
Principal Investigator
Duke University Medical Center: Transplantation
Scott Sanoff, MD, Ph.D.
Principal Investigator
Duke University Medical Center: Transplantation
Eligibility Criteria
This trial is for kidney transplant patients experiencing rejection more than 6 months post-transplant or persistent ABMR less than 6 months after. Participants must be on standard immunosuppression and steroids but still have active chronic ABMR.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive carfilzomib and belatacept therapy along with steroids and maintenance immunosuppression
Extended Treatment
Participants continue receiving belatacept, mycophenolate, prednisone, and tacrolimus
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Belatacept
- Carfilzomib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor