KTRSensor Scotland Study
Research type
Research Study
Full title
Measurement of urinary Granzyme B levels in acute cell mediated transplant rejection in Kidney Transplant Patients
IRAS ID
351414
Contact name
Marc Vendrell
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Kidney transplant is the single most effective treatment for end-stage renal failure with established benefits to survival and quality of life. Unfortunately, one in ten transplant patients experience an episode of acute transplant rejection (ATR). This is where the immune system detects the transplanted kidney as a foreign organ and initiates an immune response to attack the kidney. This threatens the function of the transplant and, if not treated, ultimately leads to failure of the organ.
Most episodes of ATR are asymptomatic and changes to renal function measured in blood tests can be due to many causes, so are not specific to ATR. This makes diagnosis of ATR particularly challenging.
The current gold standard for diagnosis of ATR is a biopsy of the transplant, this involves a needle passing through the abdominal wall to the kidney. It is uncomfortable for patients and comes with risks of bleeding and damage to the kidney.
Cells of the immune system that bring about the response in ATR release a substance - granzyme B. This has been successfully identified in the urine of patients who have ATR confirmed with biopsy. This research group has developed a fluorescent test which, when urine is added with granzyme B present, lights up. The test can be performed within the clinic, and takes only 30 minutes to get a result. The aim of this study is to investigate whether this new test can accurately diagnose acute transplant rejection.Participants recruited will have recently undergone a renal transplant. They will provide urine samples when attending for routine post-operative appointments throughout the first year (observation period). Clinical data will be collected from patient records to allow for the urine results to be interpreted over the observation period.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0014
Date of REC Opinion
18 Mar 2025
REC opinion
Further Information Favourable Opinion