NCT06950931

Posttranslationally Modified Fetuin-A in Urine as a Marker for Renal Dysfunction (Patients With Chronic Kidney Disease - With or Without Kidney Transplantation).

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.

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 86 (estimated)
• Sponsor: University Hospital, Martin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transplant Recipient (Kidney)
• Primary Kidney Transplantation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	uPTM-FeA	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.

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: Slovakia