Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients

What this Trial Is About

Researchers are evaluating a new blood test to detect antibodies that may form after kidney transplant. These antibodies can be hard to identify because they cause no symptoms but can damage the kidney. The study compares this new test with existing antibody tests to see how well it detects antibody-related inflammation versus other types of inflammation like urinary tract infections. It also investigates whether patients over 60 years old are less likely to experience immune reactions, such as rejection, compared to younger patients. The findings could help tailor immunosuppression treatments based on patient age groups to reduce risks associated with these drugs. The study involves three main parts: a cf-DNA arm where high-risk kidney transplant patients receive a blood test measuring donor-derived cell-free DNA between 6 to 12 months post-transplant alongside standard tests; monitoring immunological events and antibody formation in patients younger and older than 60 through routine sample collection; and developing machine learning predictive models for antibody formation in unsensitized patients within one year of transplant. Blood, urine, and ultrasound tests are part of routine care and used for research without extra visits. Participants will provide samples during regular outpatient visits, including blood for the new cf-DNA test and standard monitoring tests such as donor-specific antibodies and viral PCRs. The study tracks outcomes like antibody development, infections, graft function, and patient survival over about one year. Researchers also use machine learning to identify who is most at risk for antibody formation. No extra hospital visits beyond usual care are expected, and all testing aligns with routine post-transplant monitoring schedules.

Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients