Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05963126

Fetuin A as a Predictor of Deterioration of Renal Function in Hypertonic Patients

Commonly used parameters (creatinine, estimated glomerular filtration rate, and urine albumin/creatinine ratio) for prediction of decline of renal function are sensitive for advanced kidney impairment. Modified human urine Fetuin A (urine Fetuin A) with specific modification in urine (Fetuin A) can earlier predict the progression of kidney disease in patients with diabetes. Studies evaluating urine Fetuin A in hypertonic patients are still lacking.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava, - Department of Internal Medicine and Cardiology

Ostrava, Czech Republic, 70852, Czechia

Location status: Recruiting

Location contact

Eva Široká

SUB_INVESTIGATOR

Iveta Bystroňová, MSc

SUB_INVESTIGATOR

Janula Stromská, MD

SUB_INVESTIGATOR

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Lukáš Štos, MD

SUB_INVESTIGATOR

Pavla Jadrníčková, MD

SUB_INVESTIGATOR

Zdeněk Ramík, MD

PRINCIPAL_INVESTIGATOR

About this study

Arterial hypertension and diabetes are the most common cause of chronic kidney disease. Commonly used parameters for the evaluation of renal function (plasma creatinine, estimated glomerular filtration rate, and urine albumin/creatinine ratio) are sensitive to advanced kidney disease. Parameters predicting early kidney impairment are still lacking. Modified human urine Fetuin A with specific modification in urine (urine Fetuin A) presents a new biomarker that seems to be promising in the early prediction of kidney disease in patients with diabetes without microalbuminuria. Studies evaluating urine Fetuin A in hypertonic patients are still lacking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Arterial hypertension treated by at least one antihypertensive agent

Exclusion criteria

  • Diabetes mellitus of any type, defined as fasting glucose >7,0 mmol/l or any glycemia >11,0 mmol/l, or HbA1c>48 mmol/mol
  • Decompensated arterial hypertension defined as office blood pressure >180/110 mmHg or on Ambulatory Blood Pressure Monitoring (ABPM)
  • Patient with renal replacement therapy
  • Present rheumatoid disease (rheumatoid arthritis, systemic lupus, sclerodermia, dermatomyositis, Inflammatory Bowel Disease, etc.), positivity of antinuclear antibody (ANA) / extractable nuclear antigen (ENA) screening
  • Acute infection defined as C-Reactive Protein (CRP) >50 mg/l
  • Severe impairment of liver function defined as cirrhosis, Alanine Transaminase or ASpartate Transferase (ALT or AST) >10 µkat/l
  • Terminal incurable illness

Treatment and study plan

No intervention.

Other

No intervention.

Primary outcomes

  1. Glomerular filtration rate

    Time frame: 1 year

    Decline of glomerular filtration rate in 1-year follow-up of each patient in a total of 3 visits at times: 0 months, 6 months, and 12 months.

Secondary outcomes

  1. Urine biomarker DNLite IVD103 - primary aim

    Time frame: 1 year

    Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined as a decline of glomerular filtration rate in patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension. Diabetic nephropathy in vitro diagnostics (DNLite IVD103) is a colorimetric immunoassay intended for quantitative measurement of unique Fetuin-A with specific post-translational modification in human urine.

  2. Urine biomarker DNLite IVD103 - secondary aim

    Time frame: 1 year

    Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined in patients with manifested cardiovascular disease, dyslipidemia (yes/no).

  3. Urine biomarker DNLite IVD103 - correlation

    Time frame: 1 year

    Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

Modified Urine Fetuin A as a Predictor of Deterioration of Renal Function in Patients With Resistant and Non-resistant Hypertension

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.