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

RecruitingOBSERVATIONAL
Enrollment

282

Participants

Timeline

Start Date

October 13, 2023

Primary Completion Date

October 13, 2025

Study Completion Date

October 13, 2026

Conditions
Kidney TransplantRenal Transplant FailureKidney Transplant RejectionFrailtyKidney Transplant; ComplicationsTransplant DysfunctionDiagnosisRenal Transplant
Interventions
DIAGNOSTIC_TEST

cf-DNA

In addition to the standard of care tests, participants will have an additional blood sample (dd-cf DNA). A cohort study patients who have undergone high immunological risk kidney transplant at our centre defined as a re-transplant, where the cRF is \>20% or where there is a level 4 HLA-mismatch. We will take a single plasma sample for dd-cfDNA testing at 6-12 months post-transplant and pair this with an assessment of renal function (creatinine, eGFR), MSU, BK and CMV PCR, single antigen bead (SAB) monitoring of HLA-specific antibodies and allograft USS.

DIAGNOSTIC_TEST

Immunological Events following renal transplant in older age

Determine the overall frequency of immunological events and de novo HLA specific antibody formation in the \<60 and \>60 age population. Standard of care test taken at the different time intervals for routine storage. We will use those samples for HLA testing (either screening alone or screening and single antigen bead testing if screening yields a positive result).

OTHER

Determining Predictive Models for Post-transplant HLA-specific Antibody Formation

A machine learning model will be developed in Python using a range of pre- and post-transplant variables to determine a predictive model for de novo HLA-specific antibody following renal transplant.

Trial Locations (1)

L7 8YE

RECRUITING

Liverpool University Hospitals NHS Foundation Trust, Liverpool

All Listed Sponsors
collaborator

Kidney Research United Kingdom

UNKNOWN

lead

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV