NCT06830473

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
May 2025May 2028

First Submitted

Initial submission to the registry

February 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 5, 2025

Last Update Submit

February 9, 2026

Conditions

Kidney TransplantKidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

  • Number of participants that experience acute transplant rejection

    Defined by gold standard core biopsy, reported using the Banff histology grading.

    12 months

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SU, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine collection of midstream urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Vendrell, PhD

    University of Edinburgh

    STUDY CHAIR

Central Study Contacts

Alexander J Le Saint-Grant, MBChB

CONTACT

+44 131 651 8100Lex.LeSaint-Grant@ed.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 17, 2025

Study Start

May 16, 2025

Primary Completion (Estimated)

May 13, 2028

Study Completion (Estimated)

May 13, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)