KTRSensor Scotland Study: An Observational Study Into Predictors and Diagnosis of Kidney Transplant Rejection (KTRSensors)

KTRSensor Scotland Study: Investigating the Role of Biomarkers in Kidney Transplant Outcomes

An observational study capturing real world transplant patients in the post-operative setting aiming to further determine the utility of biomarkers to improve outcomes.

Study Overview

• Status: Recruiting
• Conditions: Kidney Disease, Chronic; Kidney Transplant

Detailed Description

A prospective longitudinal observational study capturing patients receiving kidney transplants in Scotland. The primary objective is to assess whether there are clinical biomarkers present in the urine that determine the outcome of kidney transplants and predict early graft rejection.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Alexander J Le Saint-Grant, MBChB; Phone Number: +44 131 651 8100; Email: Lex.LeSaint-Grant@ed.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SU
    • Recruiting
    • Royal Infirmary of Edinburgh
    • Contact: Alexander J Le Saint-Grant, MBChB; Email: Lex.LeSaint-Grant@ed.ac.uk
    • Principal Investigator: Tariq Farrah, MBChB
  • Glasgow, United Kingdom, G51 4TF
    • Recruiting
    • Queen Elizabeth University Hospital
    • Contact: Stephen Knight, MBChB PhD; Email: stephenknight@doctors.org.uk
    • Principal Investigator: Stephen Knight, MBChB PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population sampled from those who have recently undergone renal transplant in a Scottish transplant centre

Description

Any patient within a Scottish Transplant centre who has undergone renal transplant (+/- pancreas/islet) and is due to attend routine follow-up appointments at the index centre.

Exclusion criteria:

• no previous kidney transplant
• patient attending follow-up at a peripheral site
• unable to provide urine samples across the study duration

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that experience acute transplant rejection	Defined by gold standard core biopsy, reported using the Banff histology grading.	12 months

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Study Chair: Marc Vendrell, PhD, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Estimated): May 13, 2028
• Study Completion (Estimated): May 13, 2028

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: AC24216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No