The Use of Urinary Dickkopf 3 (u DKK3) as a New Biomarker Which Can Identify Patients at High Risk of Renal Allograft Dysfunction, Earlier That the Current Established Tests.

NCT07176806 | Not Yet Recruiting

• 1 other identifier: uDKK3 in renal transplant
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney function after a renal transplant is monitored closely, particularly in the first year, as the risk of deterioration in graft function is worrying. Graft dysfunction can lead to chronic kidney failure and graft loss. Currently, renal transplant function is mainly monitored using creatinine and estimated glomerular filtration rate (eGFR). However, these tests are not sensitive enough to detect small changes in graft function. A new test which can detect graft dysfunction in an early phase would be useful as this would help optimise treatment and prolong survival. Dickkopf -3 (DKK3) is a protein which is released by kidney cells in response to injury. High levels of the DKK3 protein in urine has been shown to have the potential to predict decline in graft function, earlier than the currently available tests, although the results show a mixed picture. Before this test is used routinely, further studies need to be carried out. We want to analyse this protein in multiple urine samples collected over 12 months in our cohort of renal transplant recipients. We will be comparing the urine DKK3 test with our currently available tests to investigate whether this test can identify patients who are at risk of graft dysfunction earlier.

Conditions

Renal Transplant Failure

Keywords

urinary DKK3, RENAL ALLOGRAFT DYSFUNCTION

Outcome Measures

Primary Outcomes (1)

• Can urinary urinary Dickkopf 3 measurement be an earlier predictor of renal allograft dysfunction compared to established laboratory parameters in renal transplant recipients?

  comparison of early changes in uDKK3 with changes in serum creatinine and eGFR at later times

  12 months

Secondary Outcomes (1)

• what concentration of uDKK3 can best predict renal allograft loss

  12 months

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of renal transplant recipients followed up for 12 months post-transplant.

You may qualify if:

• kidney transplant recipients only Longitudinal data of graft function including serum creatinine, e GFR over 12 months at specific time-points; baseline (1 week after transplantation), 3, 6 and 12 months

You may not qualify if:

• Combined kidney pancreas transplant patients with missing graft function values including serum creatinine, e GFR at the specific time-points.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas' Hospital NHS foundation Trust

London, SE1 7EH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stored urine samples

Study Officials

• Rachel Fey

  Guy's and St Thomas NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Geeta Hampson, MD

CONTACT

02071887188; geeta.hampson@kcl.ac.uk

Dimitrios Moutzouris, MD

CONTACT

07926752193; dimitrios.moutzouris@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

GB (1)