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

March 29, 2023 updated by: Value Outcomes Ltd.
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Jihomoravský Kraj
      • Brno, Jihomoravský Kraj, Czechia, 63900
        • Recruiting
        • Thetis Seirenia Brno
        • Contact:
    • Karlovarský Kraj
      • Sokolov, Karlovarský Kraj, Czechia, 35601
    • Kraj Vysočina
      • Havlíčkův Brod, Kraj Vysočina, Czechia, 58022
        • Recruiting
        • Nemocnice Havlíčkův Brod
        • Contact:
      • Jihlava, Kraj Vysočina, Czechia, 58601
        • Recruiting
        • Nemocnice Jihlava
        • Contact:
        • Sub-Investigator:
          • Jaroslav Točík, prim. MUDr.
        • Sub-Investigator:
          • Petr Knetl, MUDr.
        • Sub-Investigator:
          • Martin Winkler, MUDr.
    • Středočeský Kraj
      • Mělník, Středočeský Kraj, Czechia, 27601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with severely decreased renal function or with renal failure (CKD category 4 to 5 as per KDIGO 2012 (2), i.e., GFR < 30 ml/min/1.73 m2 for at least 3 months) naïve to dialysis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic parameters
Time Frame: through study completion, an average of 3 months
age, gender, ethnicity, health insurance company, education, marital status and cohabitation, employment status/disability, type of employment
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical history and anthropometry
Time Frame: through study completion, an average of 3 months
BMI (in kg/m^2)
through study completion, an average of 3 months
Medical history and anthropometry
Time Frame: through study completion, an average of 3 months
blood pressure (systolic/diastolic, in mmHg)
through study completion, an average of 3 months
Medical history and anthropometry
Time Frame: through study completion, an average of 3 months
time since CKD diagnosis (in years), time since stage 4 CKD (in years), previous referral to nephrology (in years)
through study completion, an average of 3 months
Medical history and anthropometry
Time Frame: through study completion, an average of 3 months
smoking, abusus
through study completion, an average of 3 months
Medical history and anthropometry
Time Frame: through study completion, an average of 3 months
aetiology of CKD, comorbidities, current pharmacotherapy
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
albumin (in g/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
glycaemia (in mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
CRP (in mg/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
serum creatinine (in μmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
serum calcium (in mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
LDL and HDL cholesterol (in mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
serum urea (in mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
plasma potassium (in mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
serum PTH (pmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
albuminuria (in mg/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
serum phosphorus (mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
haematuria (erythrocytes/μl)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
urine creatinine (mmol/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - WBC (10^9/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - RBC (10^12/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - MCV (fl)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - MCHC (g/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - HCT
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - HGB (g/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - PLT (10^9/l)
through study completion, an average of 3 months
Laboratory parameters
Time Frame: through study completion, an average of 3 months
blood count - RDW (%)
through study completion, an average of 3 months
Prognosis
Time Frame: through study completion, an average of 3 months
Bansal score (min. 0, max. 17, higher score means the worse prognosis)
through study completion, an average of 3 months
Functional status/frailty/performance
Time Frame: through study completion, an average of 3 months
Clinical frailty scale (min. 1, max. 9, higher score means higher frailty)
through study completion, an average of 3 months
Nutrition
Time Frame: through study completion, an average of 3 months
nutritional status (Full MNA assessment), ketoanalogues, salt intake, protein intake, nutritional education (flyers, consultations etc.), attitude/future adherence to prescribed dietary restrictions
through study completion, an average of 3 months
Decision of future management
Time Frame: through study completion, an average of 3 months
Choice of future management (conservative management, conservative management with ketoanalogues, dialysis)
through study completion, an average of 3 months
Physician attitude to the choice of therapy + reasons
Time Frame: through study completion, an average of 3 months
Physician motivation/reasons for treatment choices
through study completion, an average of 3 months
Patient attitude to the choice of therapy + reasons
Time Frame: through study completion, an average of 3 months
Patient motivation/reasons for treatment choices
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Value Outcomes Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NephroSCREEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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