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

Recruiting now

Conditions studied: Kidney Transplant, Renal Transplant Failure, Kidney Transplant Rejection, Frailty, Kidney Transplant; Complications, Transplant Dysfunction, Diagnosis, Renal Transplant

In brief

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 lead to kidney damage. A new blood test will be performed alongside existing antibody tests to see how well the test functions in comparison and to see how well it is able to distinguish between inflammation caused by antibodies and other sorts of inflammation such as a urinary tract infection. The investigators also want to determine whether it is predictable whom will develop antibodies after a transplant and use these results to change the current way patients are monitored for antibodies after receiving a transplant. In addition to this, the investigators want to establish if patients over 60 years of age are relatively protected against immunological events such as rejection compared to patients who are under 60 years of age. The results could potentially lead to using a different immunosuppression regime based on which population age group patients belong to and lowering the risks associated with these drugs.

Key facts

Study ID

NCT06025240

Run by

Liverpool University Hospitals NHS Foundation Trust

People needed

282

Starts

2023-10-13

Expected to finish

2026-10-13

Last updated by the study team

2024-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Liverpool University Hospitals NHS Foundation Trust — Liverpool, Merseyside, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.