Status:
RECRUITING
Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Lead Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Kidney Research United Kingdom
Conditions:
Kidney Transplant
Renal Transplant Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess a new test to detect antibodies which may form following kidney transplant. These antibodies can be difficult to detect as they do not cause any symptoms but can...
Detailed Description
Donor-derived cell-free DNA (dd-cfDNA) Post-transplant monitoring for acute rejection in most centres, focuses on identification of a deterioration in graft function which may be totally asymptomatic...
Eligibility Criteria
Inclusion
- cf-DNA arm:
- Adult patients transplanted within 6-12 months (retrospective recruitment)
- Patients admitted for renal transplant or within the first 6 months following transplant (prospective recruitment)
- Patients must have capacity to provide informed consent
- Patients must have received a high-risk transplant defined as level 4 mismatch, cRF \>20, second or subsequent transplant, ABO or HLA incompatible
- Older Age Immunological Events:
- \- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant
- Predictive models:
- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant
- Unsensitized pre-transplant
Exclusion
- cf-DNA arm:
- Transplanted for longer than 12 months;
- Low risk transplants;
- Patients lacking capacity;
- Older Age Immunological Events:
- Patients lacking capacity
- Patients transplanted longer than 2 weeks
- Predictive models:
- Sensitised patients
- Patients lacking capacity
- Patients transplanted longer than 2 weeks
Key Trial Info
Start Date :
October 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 13 2026
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT06025240
Start Date
October 13 2023
End Date
October 13 2026
Last Update
August 30 2024
Active Locations (1)
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1
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L7 8YE