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

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.

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 Overview

• Status: Enrolling by invitation
• Conditions: Transplant Recipient (Kidney); Primary Kidney Transplantation
• Intervention / Treatment: Diagnostic test: uPTM-FeA

• Study Type: Observational
• Enrollment (Estimated): 86

Contacts and Locations

Study Locations

• Slovakia
  • Martin, Slovakia, 03601
    • University hospital Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients after primary kidney transplantation, whose undergo protocolar or indication graft biopsy.

Description

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-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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of study at 4 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Martin

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): July 25, 2025
• Study Completion (Estimated): July 25, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: acute kidney injury; graft failure; kidney transplant recipient; Urinary post-translationally modified fetuin A; biopsy of native kidney
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: TNO_UNM2; grant UK /3030 /2024 (Other Grant/Funding Number: Comenius University in Bratislava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is a monocenter pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No