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RecruitingNCT05963126Updated Jul 27, 2023

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

An observational study in Arterial Hypertension, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by University Hospital Ostrava · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Arterial Hypertension

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Keywords

  • Arterial Hypertension
  • Resistant Arterial Hypertension
  • Chronic Kidney Disease
  • Fetuin A
  • DNLite IVD103
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 200 is close to the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with hypertension and resistant hypertension followed-up in the Hypertension excellence centre and Lipid centre in University Hospital Ostrava.

Inclusion criteria

  • Arterial hypertension treated by at least one antihypertensive agent

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with hypertension, resistant hypertension, and secondary hypertension

    Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension.

    Other: No intervention.

Interventions

  • OtherNo intervention.

    No intervention.

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What researchers measure

Primary outcomes

  1. Glomerular filtration rate

    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.

    Time frame: 1 year

Secondary outcomes

  1. Urine biomarker DNLite IVD103 - primary aim

    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.

    Time frame: 1 year

  2. Urine biomarker DNLite IVD103 - secondary aim

    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).

    Time frame: 1 year

  3. Urine biomarker DNLite IVD103 - correlation

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • University Hospital Ostrava, - Department of Internal Medicine and Cardiology
    Ostrava, Czech Republic 70852, Czechia
    • Jiří Hynčica · Contact · jiri.hyncica@fno.cz · 0042059737
    • Zdeněk Ramík, MD · Principal investigator
    • Iveta Bystroňová, MSc · Sub investigator
    • Janula Stromská, MD · Sub investigator
    • Pavla Jadrníčková, MD · Sub investigator
    • Lukáš Štos, MD · Sub investigator
    • Eva Široká · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963126
Lead sponsor
University Hospital Ostrava
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Jul 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 27, 2023

Study contacts

Jiří Hynčica
Contact
jiri.hyncica@fno.cz
0042059737 ext. 2587
Zdeněk Ramík, MD
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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