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Contact Information:

George E Nita, MBChB MSc MRCSEd 01517062000
george.nita@liverpoolft.nhs.uk


Petra M Goldsmith, MBBChir PhD FRCS 01517055550
petra.goldsmith@liverpoolft.nhs.uk


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Be Part of Research - Trial Details - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
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Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients

Recruiting

Open to: ALL

Age: 18.0 - N/A

Liverpool

Medical Conditions

Frailty

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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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2023 Oct 2025

OBSERVATIONAL

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : 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.

Intervention Arm Group : cf-DNA arm;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : 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).

Intervention Arm Group : Immunological Events following renal transplant in older age;

Intervention Type : OTHER
Intervention Description : 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.

Intervention Arm Group : Determining Predictive Models for Post-transplant HLA-specific Antibody Formation;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Liverpool University Hospitals NHS Foundation Trust
    Liverpool
    Merseyside
    L7 8YE

Petra M Goldsmith, MBBChir PhD FRCS 01517055550
petra.goldsmith@liverpoolft.nhs.uk


George E Nita, MBChB MSc MRCSEd 01517062000
george.nita@liverpoolft.nhs.uk



The study is sponsored by Liverpool University Hospitals NHS Foundation Trust and is in collaboration with Kidney Research United Kingdom.



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Read full details for Trial ID: NCT06025240
Last updated 28 August 2024

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