Chronic Kidney DiseasesNCT05380843
Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic
An observational study of Chronic Kidney Diseases, run by Value Outcomes Ltd. at 5 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 1,200 participants
- Where
- 5 sitesCzechia
- Study dates
- 16 May 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites, 5 recruiting
- Recruiting
Thetis Seirenia Brno
Brno, South Moravian, 63900
Stanislav Šurel, MUDr., surel@dopis.cz
- Recruiting
Nemocnice Havlíčkův Brod
Havlíčkův Brod, Vysocina, 58022
Šenk František, MUDr., fsenk@seznam.cz
- Recruiting
Nemocnice Jihlava
Jihlava, Vysocina, 58601
Alena Svobodová, MUDr., svobodovaa@nemji.cz
Jaroslav Točík, prim. MUDr.
- Recruiting
FMC Nemocnice Mělník
Mělník, Central Bohemia, 27601
Katarína Nehézová, MUDr., katarina.nehezova@fmc-ag.com
- Recruiting
FMC Sokolov
Sokolov, Carlsbad Region, 35601
Jiří Vlasák, MUDr., jiri.vlasak@fmc-ag.com
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Keywords
- epidemiological survey, renal failure, decreased renal function, dialysis, low protein diet, treatment alternatives, Clinical Frailty Scale, Mini Nutritional Assessment (MNA), Bansal Score
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic parameters
age, gender, ethnicity, health insurance company, education, marital status and cohabitation, employment status/disability, type of employment
Measured: through study completion, an average of 3 months
Secondary outcomes (32)
Medical history and anthropometry
BMI (in kg/m^2)
Measured: through study completion, an average of 3 months
Medical history and anthropometry
blood pressure (systolic/diastolic, in mmHg)
Measured: through study completion, an average of 3 months
Medical history and anthropometry
time since CKD diagnosis (in years), time since stage 4 CKD (in years), previous referral to nephrology (in years)
Measured: through study completion, an average of 3 months
Medical history and anthropometry
smoking, abusus
Measured: through study completion, an average of 3 months
Medical history and anthropometry
aetiology of CKD, comorbidities, current pharmacotherapy
Measured: through study completion, an average of 3 months
Laboratory parameters
albumin (in g/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
glycaemia (in mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
CRP (in mg/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
serum creatinine (in μmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
serum calcium (in mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
LDL and HDL cholesterol (in mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
serum urea (in mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
plasma potassium (in mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
serum PTH (pmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
albuminuria (in mg/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
serum phosphorus (mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
haematuria (erythrocytes/μl)
Measured: through study completion, an average of 3 months
Laboratory parameters
urine creatinine (mmol/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - WBC (10^9/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - RBC (10^12/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - MCV (fl)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - MCHC (g/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - HCT
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - HGB (g/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - PLT (10^9/l)
Measured: through study completion, an average of 3 months
Laboratory parameters
blood count - RDW (%)
Measured: through study completion, an average of 3 months
Prognosis
Bansal score (min. 0, max. 17, higher score means the worse prognosis)
Measured: through study completion, an average of 3 months
Functional status/frailty/performance
Clinical frailty scale (min. 1, max. 9, higher score means higher frailty)
Measured: through study completion, an average of 3 months
Nutrition
nutritional status (Full MNA assessment), ketoanalogues, salt intake, protein intake, nutritional education (flyers, consultations etc.), attitude/future adherence to prescribed dietary restrictions
Measured: through study completion, an average of 3 months
Decision of future management
Choice of future management (conservative management, conservative management with ketoanalogues, dialysis)
Measured: through study completion, an average of 3 months
Physician attitude to the choice of therapy + reasons
Physician motivation/reasons for treatment choices
Measured: through study completion, an average of 3 months
Patient attitude to the choice of therapy + reasons
Patient motivation/reasons for treatment choices
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start16 May 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Value Outcomes Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380843
- Sponsor's protocol ID
- NephroSCREEN
- Status last verified
- Mar 2023
- First submitted
- 9 May 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic
- ClinicalTrials.gov ID
- NCT05380843
- Acronym / sponsor ID
- NephroSCREEN
- Conditions
- Chronic Kidney Diseases
- Keywords
- epidemiological survey, renal failure, decreased renal function, dialysis, low protein diet, treatment alternatives, Clinical Frailty Scale, Mini Nutritional Assessment (MNA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Value Outcomes Ltd.University, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
32 secondary outcomes
Medical history and anthropometry
Time frame: through study completion, an average of 3 months
Medical history and anthropometry
Time frame: through study completion, an average of 3 months
Medical history and anthropometry
Time frame: through study completion, an average of 3 months
Medical history and anthropometry
Time frame: through study completion, an average of 3 months
Medical history and anthropometry
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Laboratory parameters
Time frame: through study completion, an average of 3 months
Prognosis
Time frame: through study completion, an average of 3 months
Functional status/frailty/performance
Time frame: through study completion, an average of 3 months
Nutrition
Time frame: through study completion, an average of 3 months
Decision of future management
Time frame: 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
Patient attitude to the choice of therapy + reasons
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Value Outcomes Ltd. at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Tužil, Mgr. (727824059 ext. +420, jan.tuzil@valueoutcomes.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic parameters (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.