NCT06025240 Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
| NCT ID | NCT06025240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Liverpool University Hospitals NHS Foundation Trust |
| Condition | Kidney Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 282 participants |
| Start Date | 2023-10-13 |
| Primary Completion | 2025-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 282 participants in total. It began in 2023-10-13 with a primary completion date of 2025-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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 2. Older Age Immunological Events: \- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant 3. Predictive models: * Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant * Unsensitized pre-transplant Exclusion Criteria: 1. cf-DNA arm: * Transplanted for longer than 12 months; * Low risk transplants; * Patients lacking capacity; 2. Older Age Immunological Events: * Patients lacking capacity * Patients transplanted longer than 2 weeks 3. Predictive models: * Sensitised patients * Patients lacking capacity * Patients transplanted longer than 2 weeks
Contact & Investigator
Petra M Goldsmith, MBBChir PhD FRCS
STUDY DIRECTOR
Liverpool University Hospitals NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06025240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06025240 currently recruiting?
Yes, NCT06025240 is actively recruiting participants. Contact the research team at george.nita@liverpoolft.nhs.uk for enrollment information.
Where is the NCT06025240 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom.
Who is sponsoring the NCT06025240 clinical trial?
NCT06025240 is sponsored by Liverpool University Hospitals NHS Foundation Trust. The principal investigator is Petra M Goldsmith, MBBChir PhD FRCS at Liverpool University Hospitals NHS Foundation Trust. The trial plans to enroll 282 participants.
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