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

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 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.

Conditions

• Kidney Transplant
• Renal Transplant Failure
• Kidney Transplant Rejection
• Frailty
• Kidney Transplant; Complications
• Transplant Dysfunction
• Diagnosis
• Renal 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.

Sponsors & Collaborators

• Kidney Research United Kingdom

  collaborator UNKNOWN

• Liverpool University Hospitals NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Petra M Goldsmith, MBBChir PhD FRCS · Liverpool University Hospitals NHS Foundation Trust

• George E Nita, MBChB MSc MRCSEd · Liverpool University Hospitals NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-13

Primary Completion

2025-10-13

Completion

2026-10-13

Countries

• United Kingdom

Study Locations