Transplant Recipient (Kidney)(uPTM-FetA)NCT06950931
Posttranslationally Modified Fetuin-A in Urine as a Marker for Renal Dysfunction (Patients With Chronic Kidney Disease - With or Without Kidney Transplantation).
An observational study of Transplant Recipient (Kidney) and Primary Kidney Transplantation, run by University Hospital, Martin at 1 site in Slovakia.
Trial summary
Kidney transplantation is the preferred treatment method for patients with chronic kidney disease. Standard parameters (estimated glomerular filtration, albuminuria) of renal function detection are limited by many factors, therefore they are considered insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Recipient (Kidney), Primary Kidney Transplantation
- What is being tested?
- uPTM-FeA
- How many people
- 86 participants
- Where
- 1 siteSlovakia
- Study dates
- 25 Jun 2024to 25 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after primary kidney transplantation, whose undergo protocolar or indication graft biopsy.
Who may be able to join
- patient age > 18 years,
- primary kidney transplantation;
- at least 12 months after kidney transplantation;
- immunosuppression: calcineurin inhibitors, mycophenolic acid analogues and corticosteroids;
- living donor or donation after brain death (DBD) donor;
- patient cooperation;
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- regular check-ups in Transplant-Nephrology surgery at University Hospital Martin;
- provision of a sample of the first-morning urine;
- signed informed consent.
Who cannot join
- • patient age < 18 years;
- secondary/tertiary kidney transplantation;
- kidney transplantation in the last 12 months;
- absence of ≥1 of the basic immunosuppressants (calcineurin inhibitors, mycophenolic acid analogues and corticosteroids);
- contaminated sample of the first-morning urine (for example, menstruation);
- non-provision of a sample of the first-morning urine;
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- disagreement of the patient with the Examination and inclusion in the study.
- Inclusion Criteria for patients without kidney transplatation:
- patient age > 18 years,
- chronic kidney injury or acute kidney injury
- performed renal biopsy
- patient cooperation;
- regular check-ups in Transplant-Nephrology surgery at University Hospital Martin;
- provision of a sample of the first-morning urine;
- signed informed consent.
- patient age < 18 years;
- absence of renal biopsy or non-represenantative sample of renal biopsy
- contaminated sample of the first-morning urine (for example, menstruation);
- non-provision of a sample of the first-morning urine;
- disagreement of the patient with the Examination and inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posttranslationally Modified Fetuin-A in the Urine as a Marker for Rejection and Prediction of Graft Function in Renal Transplant Recipients, and Concurrent Correlation of Fetuin-A and Histopalogical Findings of Glomerulopathy in Chronic Kidney Disease Patients.
Kidney transplantation is the preferred treatment method for patients with chronic kidney disease. Standard parameters (estimated glomerular filtration, albuminuria) of renal function detection are limited by many factors, therefore they are considered insufficient. Urinary post-translationally modified fetuin A (uPTM-FeA) appears to be a promising biomarker for the early detection of impaired renal function. Increased values were detected in patients with diabetic kidney disease, acute kidney injury and interstitial fibrosis/tubular atrophy.
Patients after kidney transplantation will be included in our analysis, in which the value of uPTM-FeA at the time of kidney graft biopsy performing (indication/ protocolar) and 6th months after biopsy. The study will also include the patients with chronic kidney disease after renal biopsy, when the value of uPTM-FeA be examined and then 6 months after renal biopsy. The analysis will be correlated with the basic characteristics of the donor and recipient, with the results of protocol or indication biopsy, rejection, level and dose of immunosuppression and parameters detecting renal function. The analysis will be correlated with the histopatology result of kidney biopsy.
Read more
The study also include patients with chronic kidney disease or acute kidney injury, who undergo renal biopsy. The value of uPTM-FeA be examined at the time of kidney biopsy and then 6 months after and correlated with the basic laboratory parametres and the results biopsy.
The aim of our study is to confirm the reliability of uPTM-FeA as a marker of kidney graft failure with the perspective of including uPTM-FeA examination in routine examination methods. Early detection of kidney graft failure can help save not only the graft, but also prolong the patient's life. And the second aim is correlated the value of uPTM-FeA with the severity of acute kindey injury and diagnosis of chronic kidney disease.
- Being tested
- uPTM-FeA
- Keywords
- kidney transplant recipient, Urinary post-translationally modified fetuin A, graft failure, acute kidney injury, biopsy of native kidney
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uPTM-FeADiagnostic test
In this monocentric prospective cohort study, we will measure uPTM-FeA by enzyme-linked immunosorbent assay (ELISA) kit DNLite IVD 103 in cooperation with PromedeusLab. Human uPTM3-DKD ELISA is a colourimetric immunoassay for quantitatively determining human unique Fetuin-A with specific post-translational modification (PTM) in urine.
| Study group | Role | What they receive |
|---|---|---|
| pacient with or without kindey transplantation | Adult kidney recipients at least 12 months after kidney transplantation (living donor or donor after brain death) with full immunosuppression (calcineurin inhibitors, mycophenolic acid analogues and corticosteroids). Patients undergo indication or protocolar biopsy and provide a sample of the first-morning urine.
Patients with chronic kidney disease or acute kidney injury who has undergone a kidney biopsy. Receives: Diagnostic Test: uPTM-FeA |
What is being measured
The primary outcome is the main question the study is designed to answer.
uPTM-FeA as a reliable marker of early detection of kidney graft dysfunction
The primary end-point of this study is to determine if uPTM-FeA is a reliable marker of early detection of graft function deterioration or graft failure in KTRs in correlation with UACR and eGFR (by CKD-EPI equation) and the context of biopsy-proven acute rejection.
Measured: From enrollment to the end of study at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Jun 2024
- Primary completion25 Jul 2025 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Recipient (Kidney)Studies 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950931
- Sponsor's protocol ID
- TNO_UNM2
- Other IDs
- grant UK /3030 /2024
- Acronym
- (uPTM-FetA)
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is a monocenter pilot study
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posttranslationally Modified Fetuin-A in the Urine as a Marker for Rejection and Prediction of Graft Function in Renal Transplant Recipients, and Concurrent Correlation of Fetuin-A and Histopalogical Findings of Glomerulopathy in Chronic Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT06950931
- Acronym / sponsor ID
- (uPTM-FetA) / TNO_UNM2
- Keywords
- kidney transplant recipient, Urinary post-translationally modified fetuin A, graft failure, acute kidney injury, biopsy of native kidney
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 30 Apr 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 transplantation is the preferred treatment method for patients with chronic kidney disease. Standard parameters (estimated glomerular filtration, albuminuria) of renal function detection are limited by many factors, therefore they are considered insufficient. Urinary post-translationally modified fetuin A (uPTM-FeA) appears to be a promising biomarker for the early detection of impaired renal function. Increased values were detected in patients with diabetic kidney disease, acute kidney injury and interstitial fibrosis/tubular atrophy.
Patients after kidney transplantation will be included in our analysis, in which the value of uPTM-FeA at the time of kidney graft biopsy performing (indication/ protocolar) and 6th months after biopsy. The study will also include the patients with chronic kidney disease after renal biopsy, when the value of uPTM-FeA be examined and then 6 months after renal biopsy. The analysis will be correlated with the basic characteristics of the donor and recipient, with the results of protocol or indication biopsy, rejection, level and dose of immunosuppression and parameters detecting renal function. The analysis will be correlated with the histopatology result of kidney biopsy.
The study also include patients with chronic kidney disease or acute kidney injury, who undergo renal biopsy. The value of uPTM-FeA be examined at the time of kidney biopsy and then 6 months after and correlated with the basic laboratory parametres and the results biopsy.
The aim of our study is to confirm the reliability of uPTM-FeA as a marker of kidney graft failure with the perspective of including uPTM-FeA examination in routine examination methods. Early detection of kidney graft failure can help save not only the graft, but also prolong the patient's life. And the second aim is correlated the value of uPTM-FeA with the severity of acute kindey injury and diagnosis of chronic kidney disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pacient with or without kindey transplantation | – | Diagnostic Test: uPTM-FeAAdult kidney recipients at least 12 months after kidney transplantation (living donor or donor after brain death) with full immunosuppression (calcineurin inhibitors, mycophenolic acid analogues and corticosteroids). Patients undergo indication or protocolar biopsy and provide a sample of the first-morning urine. Patients with chronic kidney disease or acute kidney injury who has undergone a kidney biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after primary kidney transplantation, whose undergo protocolar or indication graft biopsy.
Key inclusion criteria (9 listed)
- patient age > 18 years,
- primary kidney transplantation;
- at least 12 months after kidney transplantation;
- immunosuppression: calcineurin inhibitors, mycophenolic acid analogues and corticosteroids;
- living donor or donation after brain death (DBD) donor;
Key exclusion criteria (20 listed)
- • patient age < 18 years;
- patient age > 18 years,
- chronic kidney injury or acute kidney injury
- performed renal biopsy
- patient cooperation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uPTM-FeAIn this monocentric prospective cohort study, we will measure uPTM-FeA by enzyme-linked immunosorbent assay (ELISA) kit DNLite IVD 103 in cooperation with PromedeusLab. Human uPTM3-DKD ELISA is a colourimetric immunoassay for quantitatively determining human unique Fetuin-A with specific post-translational modification (PTM) in urine. | Diagnostic test | pacient with or without kindey transplantation |
Primary outcome
uPTM-FeA as a reliable marker of early detection of kidney graft dysfunction
Time frame: From enrollment to the end of study at 4 weeks
The primary end-point of this study is to determine if uPTM-FeA is a reliable marker of early detection of graft function deterioration or graft failure in KTRs in correlation with UACR and eGFR (by CKD-EPI equation) and the context of biopsy-proven acute rejection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No. It is a monocenter pilot study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplant Recipient (Kidney) and Primary Kidney Transplantation, run by University Hospital, Martin at 1 site in Slovakia.
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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 Slovakia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uPTM-FeA as a reliable marker of early detection of kidney graft dysfunction (time frame: From enrollment to the end of study at 4 weeks). 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 30 Apr 2025.