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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963126
Other study ID # MHUFA-hypertension CKD
Secondary ID RVO-FNOs/2023 17
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date December 31, 2026

Study information

Verified date July 2023
Source University Hospital Ostrava
Contact Jirí Hyncica
Phone 0042059737
Email jiri.hyncica@fno.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention.
No intervention.

Locations

Country Name City State
Czechia University Hospital Ostrava, - Department of Internal Medicine and Cardiology Ostrava Czech Republic

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
Secondary 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. 1 year
Secondary 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). 1 year
Secondary Urine biomarker DNLite IVD103 - correlation Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no). 1 year
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