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

Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963126
• Other study ID #: MHUFA-hypertension CKD
• Secondary ID: RVO-FNOs/2023 17
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

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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