Kidney TransplantKTRSensorsNCT06830473
KTRSensor Scotland Study: An Observational Study Into Predictors and Diagnosis of Kidney Transplant Rejection
An observational study of Kidney Transplant and Kidney Disease, Chronic, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
An observational study capturing real world transplant patients in the post-operative setting aiming to further determine the utility of biomarkers to improve outcomes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Transplant, Kidney Disease, Chronic
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 May 2025to 13 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population sampled from those who have recently undergone renal transplant in a Scottish transplant centre
Who may be able to join
None listed.
Who cannot join
- no previous kidney transplant
- patient attending follow-up at a peripheral site
- unable to provide urine samples across the study duration
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SU
Alexander J Le Saint-Grant, MBChB, Lex.LeSaint-Grant@ed.ac.uk
Tariq Farrah, MBChB
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Stephen Knight, MBChB PhD, stephenknight@doctors.org.uk
Stephen Knight, MBChB PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplant, Kidney Disease, Chronic
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experience acute transplant rejection
Defined by gold standard core biopsy, reported using the Banff histology grading.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start16 May 2025
- Primary completion13 May 2028 (estimated)
- Study completion13 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Vendrell, PhD, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830473
- Sponsor's protocol ID
- AC24216
- Acronym
- KTRSensors
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KTRSensor Scotland Study: Investigating the Role of Biomarkers in Kidney Transplant Outcomes
- ClinicalTrials.gov ID
- NCT06830473
- Acronym / sponsor ID
- KTRSensors / AC24216
- Conditions
- Kidney Transplant, Kidney Disease, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 13 May 2028 (estimated)
- Study completion
- 13 May 2028 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study capturing real world transplant patients in the post-operative setting aiming to further determine the utility of biomarkers to improve outcomes.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population sampled from those who have recently undergone renal transplant in a Scottish transplant centre
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- no previous kidney transplant
- patient attending follow-up at a peripheral site
- unable to provide urine samples across the study duration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants that experience acute transplant rejection
Time frame: 12 months
Defined by gold standard core biopsy, reported using the Banff histology grading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Vendrell, PhD study chair
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant and Kidney Disease, Chronic, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Le Saint-Grant, MBChB (+44 131 651 8100, Lex.LeSaint-Grant@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that experience acute transplant rejection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.