Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

NCT ID: NCT05380843

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-16

Study Completion Date

2023-06-30

Brief Summary

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The decision making in the Czech nephrology offices depends on the local common practice which is likely to be heterogenous. In other words, the same patient would be indicated to different therapy and regimen at different sites. To date, the practices and treatment paths have not been described. The aim of the present epidemiological research is to characterize the population of CKD patients at the point of treatment choice and to outline the motivation of nephrologist to initiate particular therapy.

Detailed Description

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This is epidemiological (observational) cross-sectional survey. Data for the research will be obtained from clinical records and patient´s questionnaires and transcribed into electronic case report forms (eCRF) by physician anonymized using subject ID.

This observational research will not impose any additional procedures, assessments, or changes in addition to the routine management of subjects.

The research does not aim to follow treatment with a single medicinal product. The management of patients will be described in general terms. Names of active substances will be collected rather than the names of individual products.

Conditions

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Chronic Kidney Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Adult patient of 18 years and older
* Signed consent with processing of personal data as per the GDPR and the applicable national legal requirements
* Chronic kidney disease (CKD) category 4 to 5 characterized by GFR \< 30 ml/min/1.73m2 for at least 3 months

Exclusion Criteria

* Patients on chronic dialysis
* Patient waiting for kidney transplant
* Patient requiring indication of dialysis (e.g., life-threatening changes in fluid, electrolyte, and acid-base balance, serositis, pruritus, inability to control blood pressure, lethargy or other changes in mental status, symptoms of uraemia, GFR \< 10 ml/min/1.73 m2)
* Patient with altered mental state unable to fill patient questionnaires
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Value Outcomes Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FMC Nemocnice Mělník

Mělník, Central Bohemia, Czechia

Site Status RECRUITING

FMC Sokolov

Sokolov, Karlovarský kraj, Czechia

Site Status RECRUITING

Nemocnice Havlíčkův Brod

Havlíčkův Brod, Kraj Vysočina, Czechia

Site Status RECRUITING

Nemocnice Jihlava

Jihlava, Kraj Vysočina, Czechia

Site Status RECRUITING

Thetis Seirenia Brno

Brno, South Moravian, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jan Tužil, Mgr.

Role: CONTACT

727824059 ext. +420

Facility Contacts

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Katarína Nehézová, MUDr.

Role: primary

Jiří Vlasák, MUDr.

Role: primary

Šenk František, MUDr.

Role: primary

Alena Svobodová, MUDr.

Role: primary

Stanislav Šurel, MUDr.

Role: primary

Other Identifiers

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NephroSCREEN

Identifier Type: -

Identifier Source: org_study_id

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