New blood test for detecting antibodies in kidney transplant patients

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

This study is testing a new blood test to see if it can better detect harmful antibodies in kidney transplant patients compared to current tests, helping to prevent damage to their transplanted kidney.

Quick facts

• Study type: Observational
• Enrollment: 282 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Liverpool University Hospitals NHS Foundation Trust (other gov)
• Locations: 1 site (Liverpool, Merseyside)
• Trial ID: NCT06025240 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate a novel blood test for detecting HLA-specific antibodies that may develop after kidney transplantation. It will compare the effectiveness of this new test against existing antibody tests to identify inflammation caused by antibodies versus other causes like urinary tract infections. Additionally, the study seeks to predict which patients are likely to develop these antibodies and assess the immunological responses in patients over 60 years of age. The goal is to improve monitoring practices for kidney transplant recipients and potentially prevent graft damage.

Who should consider this trial

Good fit: Ideal candidates include adult patients who have undergone a kidney transplant within the last 6-12 months or are about to undergo a transplant.

Not a fit: Patients who have been transplanted for longer than 12 months or those with low-risk transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of antibody-mediated rejection in kidney transplant patients, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using donor-derived cell-free DNA as a biomarker for graft injury, indicating potential success for this approach.

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

Where this trial is running

Liverpool, Merseyside

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

Study contacts

• Principal investigator: George E Nita, MBChB MSc MRCSEd — Liverpool University Hospitals NHS Foundation Trust
• Study coordinator: George E Nita, MBChB MSc MRCSEd

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