Actively Recruiting

Age: 18Years +
All Genders
NCT06025240

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

Led by Liverpool University Hospitals NHS Foundation Trust · Updated on 2024-08-30

282

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

L

Liverpool University Hospitals NHS Foundation Trust

Lead Sponsor

K

Kidney Research United Kingdom

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients transplanted within 6 to 12 months (retrospective recruitment)
  • Patients admitted for kidney 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
  • Any adult patient with capacity undergoing, or within 72 hours of, a kidney transplant
  • Any adult patient with capacity undergoing, or within 72 hours of, a kidney transplant who is unsensitized pre-transplant
Not Eligible

You will not qualify if you...

  • Transplanted for longer than 12 months (cf-DNA arm)
  • Low risk transplants (cf-DNA arm)
  • Patients lacking capacity
  • Patients transplanted longer than 2 weeks (Older Age Immunological Events and Predictive models)
  • Sensitized patients (Predictive models)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, United Kingdom, L7 8YE

Actively Recruiting

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Research Team

G

George E Nita, MBChB MSc MRCSEd

CONTACT

P

Petra M Goldsmith, MBBChir PhD FRCS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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