KTRSensor Scotland Study: An Observational Study Into Pre... | NCT06830473

Studies
KTRSensor Scotland Study: An Observational Study Into Predictors and Diagnosis of Kidney Transplant Rejection

NCT06830473

Sponsor

University of Edinburgh

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Kidney Transplant
Kidney Disease, Chronic

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2025Actual

Primary Completion Date

May 13, 2028Estimated

Completion Date

May 13, 2028Estimated

First Submitted Date

Feb 5, 2025

First Submission Date that Met QC Criteria

Feb 11, 2025

First Posted Date

Feb 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander J Le Saint-Grant, MBChB	Contact	+44 131 651 8100		Lex.LeSaint-Grant@ed.ac.uk

Overall Officials

Name	Affiliation	Role
Marc Vendrell, PhD	University of Edinburgh	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Infirmary of Edinburgh	Recruiting	Edinburgh		EH16 4SU	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided