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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380843
• Other study ID #: NephroSCREEN
• Status: Recruiting
• Start date: May 16, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Value Outcomes Ltd.
• Contact: Jan Tužil, Mgr.
• Phone: 727824059
• Email: jan.tuzil[@]valueoutcomes.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Czechia	Thetis Seirenia Brno	Brno	Jihomoravský Kraj
Czechia	Nemocnice Havlíckuv Brod	Havlíckuv Brod	Kraj Vysocina
Czechia	Nemocnice Jihlava	Jihlava	Kraj Vysocina
Czechia	FMC Nemocnice Melník	Melník	Stredoceský Kraj
Czechia	FMC Sokolov	Sokolov	Karlovarský Kraj

Sponsors (1)

Lead Sponsor	Collaborator
Value Outcomes Ltd.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociodemographic parameters	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	Medical history and anthropometry	BMI (in kg/m^2)	through study completion, an average of 3 months
Secondary	Medical history and anthropometry	blood pressure (systolic/diastolic, in mmHg)	through study completion, an average of 3 months
Secondary	Medical history and anthropometry	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
Secondary	Medical history and anthropometry	smoking, abusus	through study completion, an average of 3 months
Secondary	Medical history and anthropometry	aetiology of CKD, comorbidities, current pharmacotherapy	through study completion, an average of 3 months
Secondary	Laboratory parameters	albumin (in g/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	glycaemia (in mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	CRP (in mg/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	serum creatinine (in µmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	serum calcium (in mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	LDL and HDL cholesterol (in mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	serum urea (in mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	plasma potassium (in mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	serum PTH (pmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	albuminuria (in mg/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	serum phosphorus (mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	haematuria (erythrocytes/µl)	through study completion, an average of 3 months
Secondary	Laboratory parameters	urine creatinine (mmol/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - WBC (10^9/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - RBC (10^12/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - MCV (fl)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - MCHC (g/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - HCT	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - HGB (g/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - PLT (10^9/l)	through study completion, an average of 3 months
Secondary	Laboratory parameters	blood count - RDW (%)	through study completion, an average of 3 months
Secondary	Prognosis	Bansal score (min. 0, max. 17, higher score means the worse prognosis)	through study completion, an average of 3 months
Secondary	Functional status/frailty/performance	Clinical frailty scale (min. 1, max. 9, higher score means higher frailty)	through study completion, an average of 3 months
Secondary	Nutrition	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
Secondary	Decision of future management	Choice of future management (conservative management, conservative management with ketoanalogues, dialysis)	through study completion, an average of 3 months
Secondary	Physician attitude to the choice of therapy + reasons	Physician motivation/reasons for treatment choices	through study completion, an average of 3 months
Secondary	Patient attitude to the choice of therapy + reasons	Patient motivation/reasons for treatment choices	through study completion, an average of 3 months