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

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Older Age Immunological Events:

• \- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant

• Predictive models:

‣ Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant

⁃ Unsensitized pre-transplant

Locations
Other Locations
United Kingdom
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
Contact Information
Primary
George E Nita, MBChB MSc MRCSEd
george.nita@liverpoolft.nhs.uk
01517062000
Backup
Petra M Goldsmith, MBBChir PhD FRCS
petra.goldsmith@liverpoolft.nhs.uk
01517055550
Time Frame
Start Date: 2023-10-13
Estimated Completion Date: 2026-10-13
Participants
Target number of participants: 282
Treatments
cf-DNA arm
Participants will be recruited on the basis of having received a renal transplant within the last 6-12 months which has been deemed high risk. They will be identified from a database currently held within the renal transplant unit by members of the direct care team. They will be approached at a routine outpatient appointment for inclusion into the study and testing can be performed at their time of routine post-transplant testing where they will undergo blood (dd-cf DNA NGS assay), standard of care tests: blood count, renal profile, donor specific antibodies (DSA) sample, BK virus PCR, CMV PCR, urine testing and an ultrasound of the graft.
Immunological Events following renal transplant in older age
The renal transplant population will be divided on the basis of age into two cohort: ≥60 and \<60. All renal transplant patients are regularly followed up in the outpatient clinic where blood and urine tests are collected, and clinical evaluations are performed. It is not foreseen that this study will necessitate any additional hospital visits or testing above and beyond the usual standard of care. Serum samples are taken at the time intervals indicated for routine storage and we will simply use those samples for HLA testing (either screening alone or screening and single antigen bead testing if screening yields a positive result).
Determining Predictive Models for Post-transplant HLA-specific Antibody Formation
A subset of the cohort of recruits to the immunological factors in older age study will be used to determine machine learning algorithms of predictive factors for the development of de novo donor specific antibody. Only patients who were unsensitised prior to the kidney transplant will be included into the study because prior sensitisation makes determining de novo specificities much harder. The follow up period will be set at 1 year to synchronise with the older age study.
Sponsors
Leads: Liverpool University Hospitals NHS Foundation Trust
Collaborators: Kidney Research United Kingdom

This content was sourced from clinicaltrials.gov