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

Launched by LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new blood test that aims to detect specific antibodies in kidney transplant patients. These antibodies can develop after a transplant and can cause damage to the kidney without showing any obvious symptoms. The study will compare this new test with existing methods to see how effective it is at identifying these antibodies and distinguishing between inflammation caused by them and other issues, like a urinary tract infection. Additionally, researchers want to understand if older patients (over 60 years) are less likely to experience complications like kidney rejection compared to younger patients. This information could help doctors monitor kidney transplant patients more effectively and tailor treatment plans based on age.

To be eligible for this trial, participants should be adults who are either in the early stages after a kidney transplant (within 6-12 months) or undergoing a transplant. Specifically, those with high-risk transplants or who have not been sensitized before the transplant may qualify. Participants will undergo the new blood test and existing tests, providing valuable information to improve kidney transplant care. It's important to note that individuals who have been transplanted for longer than 12 months or who are at low risk for rejection may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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
• 2. Older Age Immunological Events:
• • - Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant
• 3. Predictive models:
• • Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant
• • Unsensitized pre-transplant
• Exclusion Criteria:
• 1. cf-DNA arm:
• • Transplanted for longer than 12 months;
• • Low risk transplants;
• • Patients lacking capacity;
• 2. Older Age Immunological Events:
• • Patients lacking capacity
• • Patients transplanted longer than 2 weeks
• 3. Predictive models:
• • Sensitised patients
• • Patients lacking capacity
• • Patients transplanted longer than 2 weeks