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

Launched by UNIVERSITY HOSPITAL, MARTIN · Apr 22, 2025

Keywords

ClinConnect Summary

This study is checking whether a urine marker called uPTM-FeA can reliably detect problems with kidney grafts (the transplanted kidney) earlier than usual tests. Researchers will look at how uPTM-FeA levels relate to standard measures of kidney function (like eGFR and urine protein) and to what doctors see on kidney biopsy. They want to know if this urine test can help identify graft dysfunction or rejection sooner, which could help protect the transplant and possibly improve outcomes for people with kidney disease.

About 86 adults in Slovakia are being invited to join, at University Hospital Martin. Eligible participants include: adults 18 or older who are at least 12 months after a primary kidney transplant and are on standard medicines to prevent rejection, undergoing either a planned or a problem-motivated biopsy; or adults with chronic kidney disease or acute kidney injury who are having a kidney biopsy. Participants will provide a first-morning urine sample and have the urine tested for uPTM-FeA, with follow-up around the time of biopsy and again about six months later. This is an observational, single-center pilot study, so it won’t change anyone’s treatment; it’s mainly to learn whether uPTM-FeA could become part of routine kidney monitoring in the future.

Gender

ALL

Eligibility criteria

• 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.