Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in R
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 fu
| Condition(s) | Kidney Transplant, Renal Transplant Failure, Kidney Transplant Rejection, Frailty, Kidney Transplant; Complications, Transplant Dysfunction, Diagnosis, Renal Transplant |
|---|---|
| Status | Recruiting |
| 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 ove |
| Who can participate | 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; |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Liverpool University Hospitals NHS Foundation Trust |
| Locations | Liverpool, Merseyside, United Kingdom |
| Start date | 2023-10-13 |
| NCT ID | NCT06025240 |
| Official listing | https://clinicaltrials.gov/study/NCT06025240 |