Measurement of Granzyme B activity in renal transplant patients
Research type
Research Study
Full title
Measurement of Granzyme B activity in renal transplant patients: a feasibility pilot study
IRAS ID
315338
Contact name
Stephen Knight
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Kidney transplantation remains the single most effective treatment for end-stage kidney failure. Around one in five patients will experience acute rejection within the first year of receiving a renal transplant and is associated with an increased risk of graft loss and death. Therefore, the early detection and effective treatment of acute transplant rejection is critical to maximise graft function and quality of life for patients.
The gold standard investigation for detecting acute rejection involves taking a sample of material from the transplanted kidney, called a core biopsy. However, this is an invasive test which can cause harm to patients and for one in ten cases does not provide adequate tissue for diagnosis.
Granzyme B (GzmB) is a protein associated with acute transplant rejection and the measurement of its activity can identify the early stages of rejection with high accuracy. GzmB can be present in urine, but current methods require expensive equipment and sample processing. We propose to develop a simple, bedside urine test that sensitively measures active GzmB in real time. This will enable the early identification of acute rejection, reduce clinical dependence on invasive investigations, and encourage prompt treatment to maintain and prolong renal transplant function for patients.
Urine samples, taken routinely from renal transplant patients, will be used to determine if a previously patented probe is able to detect Granzyme B, both in patients not suspected and those suspected of having acute rejection. This will provide pilot data which will help to inform future studies.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
22/ES/0046
Date of REC Opinion
20 Dec 2022
REC opinion
Further Information Favourable Opinion