Posttranslationally Modified Fetuin-A in Urine as a Marker for Renal Dysfunction (Patients With C… (NCT06950931) | Clinical Trial Compass
By InvitationNot Applicable
Posttranslationally Modified Fetuin-A in Urine as a Marker for Renal Dysfunction (Patients With Chronic Kidney Disease - With or Without Kidney Transplantation).
Slovakia86 participantsStarted 2024-06-25
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for patients with kidney transplatation:
* 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;
* regular check-ups in Transplant-Nephrology surgery at University Hospital Martin;
* provision of a sample of the first-morning urine;
* signed informed consent.
Exclusion Criteria with kidney transplatation:
* • 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;
* 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.
Exclusion Criteria with kidney transplatation:
* patient age \< 18 years;
* absence of renal biopsy or non-represenan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
uPTM-FeA as a reliable marker of early detection of kidney graft dysfunction
Timeframe: From enrollment to the end of study at 4 weeks