Renal Transplant FailureNCT07176806
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.
An observational study of Renal Transplant Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Renal Transplant Failure
- How many people
- 258 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2026to Jan 2027
- 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 17 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: A cohort of renal transplant recipients followed up for 12 months post-transplant.
Who may be able to join
- 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
Who cannot join
- Combined kidney pancreas transplant patients with missing graft function values including serum creatinine, e GFR at the specific time-points.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's and St Thomas' Hospital NHS foundation Trust
London, SE1 7EH
About this study
Official title: The Usefulness of Urinary Dickkopf 3 (u DKK3) as a Biomarker of Renal Allograft Dysfunction in Renal Transplant Recipients
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.
Read the detailed description
Frequent monitoring of allograft function is crucial in renal transplant recipients, particularly in the first year. The current routine laboratory tests such as creatinine, glomerular filtration rate (GFR) are not ideal at detecting early allograft dysfunction or predicting allograft survival trajectory.
Urine Dickkopf 3 (u DKK3), a new biomarker, may identify patients at high risk of allograft dysfunction, earlier that the current established tests. Further investigations are needed to assess (1) its predictive ability (2) how it can help guide earlier intervention to improve graft survival, reducing the return to dialysis which is costly.
Kidney transplantation is the optimal treatment choice for patients with end-stage renal disease (ESRD). However, the risk of graft dysfunction and graft loss remains a concern and challenge. Renal transplant function is mainly evaluated using routine laboratory parameters such as creatinine and glomerular filtration rate (GFR). Transplant biopsy is the gold standard for diagnosing rejection. These tests, however, have several limitations. Serum creatinine tends to increase late in injury and is not able to predict the progression of allograft dysfunction or allograft survival trajectory. Renal biopsy cannot be used to monitor progression because it is an invasive procedure and cannot be done serially. Better graft monitoring with introduction of novel biomarkers to identify or predict patients who are at risk of declining graft function early is needed. The development of biomarkers as predictive tools for early detection of injury before pathological and clinical changes after renal transplantation is needed for targeted, individualised treatment. Advances in genomics and proteomics have allowed the identification of biomarkers which are undergoing trials in the field of transplantation and could enter clinical practice to ensure better risk assessment (1).
Dickkopf-related protein 3 (DKK3) is a secreted glycoprotein. It is synthesized by stressed tubular epithelial cells and modulates the Wnt/b-catenin pathway which is one of the important signaling pathways leading to kidney disease. DKK3 accelerates renal interstitial fibrosis and tubular atrophy through the Wnt signaling pathway. Low expression of DKK3, in mouse models, leads to improvement of tubular atrophy and reduces renal fibrosis. Other pathways may also be modulated by DKK3 as it has been shown to promote epithelial-mesenchymal transition, activate transforming growth factor-b, facilitate the inflammatory T cell response, and impair angiogenic competence, all of which contributes to renal fibrosis (2). Studies in CKD have shown that high levels of DKK3 are associated with increased tubulointerstitial fibrosis concluding that DKK3 can be tested in the clinical setting as a biomarker for patients who are at risk of loss of GFR over time, irrespective of the underlying molecular or pathological mechanisms (2). Thus, longitudinal assessment of this non-invasive marker could be of value in renal transplant recipients at predicting allograft dysfunction early thus allowing early intervention and treatment as graft loss is associated with higher mortality. Furthermore, the return to dialysis has a negative impact on quality of life and is costly. To date, there have been 2 studies looking at whether uDKK3 levels are predictive of future renal transplant function in transplant recipients (3, 4). One study, albeit in a small cohort (n=122), looked at the relationship between the rate of change in u DKK3 from 3 to 12 months and demonstrated that an increase of > 25% showed a higher risk of graft dysfunction, equivalent of a reduction of GFR of 9-10 ml/min (3). The more recent second study only measured uDKK3 at a single time point (n=82) and calculated a u DKK3 cut-off value of 1650 pg/ml as the best possible cut-off using ROC analysis and the Youden index. Their analysis showed a higher incidence of allograft loss in patients with u DKK3 > 1650 pg/ml (4). It remains to be seen which is the best discriminator, the rate of change of u DKK3 or the cut-off value. Moreover, applying a threshold would be method or assay dependent. Indeed, the authors used an assay which had been validated for serum and adapted it to measure urine samples (4). In conclusion, both studies concluded that uDKK3 may have potential as a predictor of graft function and could be a useful parameter in follow up of these patients. However, further studies are needed to expand on these findings as there are still many unanswered questions before implementation and adoption of this biomarker in clinical practice.
- Conditions
- Renal Transplant Failure
- Keywords
- urinary DKK3, RENAL ALLOGRAFT DYSFUNCTION
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
what concentration of uDKK3 can best predict renal allograft loss
Derive a cut-off value of u DKK3 as best discriminator of allograft loss
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 posted16 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant FailureStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Fey, Study director, Guy's and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176806
- Sponsor's protocol ID
- uDKK3 in renal transplant
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be made available to other researchers upon application by the researchers and review by the renal research board.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Urinary Dickkopf 3 (u DKK3) as a Biomarker of Renal Allograft Dysfunction in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT07176806
- Acronym / sponsor ID
- uDKK3 in renal transplant
- Conditions
- Renal Transplant Failure
- Keywords
- urinary DKK3, RENAL ALLOGRAFT DYSFUNCTION
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Sep 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.
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.
Detailed description
Frequent monitoring of allograft function is crucial in renal transplant recipients, particularly in the first year. The current routine laboratory tests such as creatinine, glomerular filtration rate (GFR) are not ideal at detecting early allograft dysfunction or predicting allograft survival trajectory.
Urine Dickkopf 3 (u DKK3), a new biomarker, may identify patients at high risk of allograft dysfunction, earlier that the current established tests. Further investigations are needed to assess (1) its predictive ability (2) how it can help guide earlier intervention to improve graft survival, reducing the return to dialysis which is costly.
Kidney transplantation is the optimal treatment choice for patients with end-stage renal disease (ESRD). However, the risk of graft dysfunction and graft loss remains a concern and challenge. Renal transplant function is mainly evaluated using routine laboratory parameters such as creatinine and glomerular filtration rate (GFR). Transplant biopsy is the gold standard for diagnosing rejection. These tests, however, have several limitations. Serum creatinine tends to increase late in injury and is not able to predict the progression of allograft dysfunction or allograft survival trajectory. Renal biopsy cannot be used to monitor progression because it is an invasive procedure and cannot be done serially. Better graft monitoring with introduction of novel biomarkers to identify or predict patients who are at risk of declining graft function early is needed. The development of biomarkers as predictive tools for early detection of injury before pathological and clinical changes after renal transplantation is needed for targeted, individualised treatment. Advances in genomics and proteomics have allowed the identification of biomarkers which are undergoing trials in the field of transplantation and could enter clinical practice to ensure better risk assessment (1).
Dickkopf-related protein 3 (DKK3) is a secreted glycoprotein. It is synthesized by stressed tubular epithelial cells and modulates the Wnt/b-catenin pathway which is one of the important signaling pathways leading to kidney disease. DKK3 accelerates renal interstitial fibrosis and tubular atrophy through the Wnt signaling pathway. Low expression of DKK3, in mouse models, leads to improvement of tubular atrophy and reduces renal fibrosis. Other pathways may also be modulated by DKK3 as it has been shown to promote epithelial-mesenchymal transition, activate transforming growth factor-b, facilitate the inflammatory T cell response, and impair angiogenic competence, all of which contributes to renal fibrosis (2). Studies in CKD have shown that high levels of DKK3 are associated with increased tubulointerstitial fibrosis concluding that DKK3 can be tested in the clinical setting as a biomarker for patients who are at risk of loss of GFR over time, irrespective of the underlying molecular or pathological mechanisms (2). Thus, longitudinal assessment of this non-invasive marker could be of value in renal transplant recipients at predicting allograft dysfunction early thus allowing early intervention and treatment as graft loss is associated with higher mortality. Furthermore, the return to dialysis has a negative impact on quality of life and is costly. To date, there have been 2 studies looking at whether uDKK3 levels are predictive of future renal transplant function in transplant recipients (3, 4). One study, albeit in a small cohort (n=122), looked at the relationship between the rate of change in u DKK3 from 3 to 12 months and demonstrated that an increase of > 25% showed a higher risk of graft dysfunction, equivalent of a reduction of GFR of 9-10 ml/min (3). The more recent second study only measured uDKK3 at a single time point (n=82) and calculated a u DKK3 cut-off value of 1650 pg/ml as the best possible cut-off using ROC analysis and the Youden index. Their analysis showed a higher incidence of allograft loss in patients with u DKK3 > 1650 pg/ml (4). It remains to be seen which is the best discriminator, the rate of change of u DKK3 or the cut-off value. Moreover, applying a threshold would be method or assay dependent. Indeed, the authors used an assay which had been validated for serum and adapted it to measure urine samples (4). In conclusion, both studies concluded that uDKK3 may have potential as a predictor of graft function and could be a useful parameter in follow up of these patients. However, further studies are needed to expand on these findings as there are still many unanswered questions before implementation and adoption of this biomarker in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort of renal transplant recipients followed up for 12 months post-transplant.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Combined kidney pancreas transplant patients with missing graft function values including serum creatinine, e GFR at the specific time-points.
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
Can urinary urinary Dickkopf 3 measurement be an earlier predictor of renal allograft dysfunction compared to established laboratory parameters in renal transplant recipients?
Time frame: 12 months
comparison of early changes in uDKK3 with changes in serum creatinine and eGFR at later times
1 secondary outcome
what concentration of uDKK3 can best predict renal allograft loss
Time frame: 12 months
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 16 Sep 2025.
- Individual participant dataSharing planned: Undecided. This will be made available to other researchers upon application by the researchers and review by the renal research board.
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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.
Rachel Fey study director
Guy's and St Thomas NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Geeta Hampson, MD (02071887188 ext. 81284, geeta.hampson@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can urinary urinary Dickkopf 3 measurement be an earlier predictor of renal allograft dysfunction compared to established laboratory parameters in renal transplant recipients? (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 16 Sep 2025.