Testing for non-HLA specific antibodies in a renal transplant cohort

  • Research type

    Research Study

  • Full title

    Establishing the baseline population characteristics, and evaluating the clinical utility, of 60 non-HLA specific antibody targets in a large well characterised UK renal transplant cohort, utilising commercially available testing kits

  • IRAS ID

    346470

  • Contact name

    Judith Worthington

  • Contact email

    Judith.Worthington@mft.nhs.uk

  • Sponsor organisation

    Synlab UK & Ireland

  • Duration of Study in the UK

    2 years, 3 months, 28 days

  • Research summary

    Human leucocyte antigens (HLA) are highly variable between individuals where non-self HLA can be targets of the immune system as they are seen as ‘foreign’ and result in an immune response. Antibodies to these ‘foreign’ non-self HLA can be a barrier to successful transplantation if the donor kidney expresses these targets. It is well established that these antibodies play a role in antibody mediated rejection (AMR) and graft failure in kidney transplantation, with their presence being correlated with poorer transplant outcomes. Laboratory testing aims to avoid transplanting patients who have HLA antibodies directed towards their donor and assist in the diagnosis of AMR post-transplant.

    As part of the diagnosis of AMR, it is required that there is evidence of donor specific antibody (DSA) which can be HLA and non-HLA. Whilst there is significant evidence around the role of HLA-DSA, there is limited evidence of the role non-HLA. This may mean that some diagnoses of AMR are missed and the guidance around appropriate treatment is insufficient. Therefore, work is required to identify non-HLA targets of the immune system that may contribute to AMR. Commercially available technology is available to detect non-HLA antibody and a number of targets have been identified such as angiotensin II type 1 receptor (AT1R), endothelin type A receptor (ETAR) and glutathione S-transferase theta-1 (GSTT1). However, there is not enough evidence and understanding to use this technology to guide clinical advice.

    This research project proposes to retrospectively test samples using a non-HLA antibody testing kit taken before and after transplant, to identify whether patients have non-HLA antibodies. Also, the non-HLA antibody profiles of healthy, non-transplanted volunteers will aid in determining the baseline characteristics of the non-HLA testing kit and determine what is 'normal' in healthy individuals.

  • REC name

    London - Queen Square Research Ethics Committee

  • REC reference

    25/LO/0298

  • Date of REC Opinion

    21 Jul 2025

  • REC opinion

    Further Information Favourable Opinion