Status:
ACTIVE_NOT_RECRUITING
Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Rejection Chronic Renal
Kidney Transplant Rejection
Eligibility:
All Genders
18+ years
Brief Summary
Our group recently reported that tocilizumab, a humanized monoclonal antibody against the IL-6 receptor, may be effective when administered monthly to patients with chronic antibody-mediated rejection...
Detailed Description
Chronic antibody-mediated rejection (ABMR) is now recognized as the leading cause of late kidney transplant failure (1). A number of new immunosuppressive medications have been introduced to the field...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Enrolled within six months of biopsy-proven evidence of chronic active ABMR defined by Banff 2017 diagnostic criteria
- Evidence of DSA detected in the blood within 6 months prior to consent.
- Able to understand and provide informed consent.
Exclusion
- Known contraindications for therapy with tocilizumab:
- Hypersensitivity
- Elevated liver enzymes
- Patients at risk for GI perforation
- Absolute neutrophil count \<500/mm3
- Platelet count \<50,000/mm3
- Active infection
- Contraindications for kidney transplant biopsy, including bleeding diathesis or technical/anatomical infeasibility for biopsy.
- Contraindications to donor-derived cell-free DNA (AlloSure) testing:
- Recipient of multiple transplanted organs.
- Recipient of a transplant from an identical twin.
- Pregnant
- Under the age of 18.
- Less than two weeks post-transplant.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03859388
Start Date
March 1 2019
End Date
December 31 2025
Last Update
April 24 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048