Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet

October 16, 2018 updated by: Fresenius Kabi

Characterisation of Patient Profile and Contemporary Treatment of Pre-dialytic Chronic Kidney Disease (CKD) in Patients Receiving a Restricted Protein Diet Supplemented With Ketosteril® - a Drug Utilisation Study (DUS)

The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Contacts and Locations

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

Study Locations

  • Hungary
      • Velence, Hungary, 2481
        • Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in Czech Republic, Hungary and Romania.

Description

Inclusion Criteria:

  • written informed consent
  • non-dialyzed patients with CKD
  • indication for Ketosteril according to Summary of Product Characteristics (SmPC), including a glomerular filtration rate (GFR) < 25 mL/min
  • accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
  • adult patients ≥ 18 years

Exclusion Criteria:

  • active cancer diseases
  • pregnancy or breast feeding
  • hypersensitivity to active substances or to any of the excipients in Ketosteril
  • hypercalcaemia
  • major disorder of amino acid metabolism, e.g., hereditary diseases
  • participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
  • illiteracy or incapability to read or write

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chronic kidney disease (pre-dialysis)
Observational study: Supplemented protein-restricted diet
Other: Observational study: Supplemented protein-restricted diet
Observational study: Supplemented protein-restricted diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient compliance to Ketosteril (number of tablets taken; patient-reported)
Time Frame: Daily, for a total of 12 months
This is an observational study aiming to characterise the patient profile and contemporary treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted protein diet supplemented with Ketosteril® . There is no distinction between primary and secondary outcome measures in the observational plan, and only routine procedures are documented.
Daily, for a total of 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient compliance to diet (protein and energy intake, based on a routine 3-day food diary)
Time Frame: Monthly starting 1 month after enrolment, for a total of 12 months
This is an observational study aiming to characterise the patient profile and contemporary treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted protein diet supplemented with Ketosteril® . There is no distinction between primary and secondary outcome measures in the observational plan, and only routine procedures are documented.
Monthly starting 1 month after enrolment, for a total of 12 months
CKD stage (according to KDIGO guideline)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Presence of comorbidities
Time Frame: At baseline
e.g., diabetes, hypertension, metabolic syndrome
At baseline
Serum creatinine
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
24h urinary protein
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Urinary microalbumin
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum urea
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Creatinine clearance
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Glomerular filtration rate (GFR)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Estimated glomerular filtration rate (eGFR)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Fasting blood glucose
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Fasting plasma glucose
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
HbA1c
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum triglyceride
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum cholesterol
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum high-density lipoprotein (HDL)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum low-density lipoprotein (LDL)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum calcium
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum phosphate
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum parathyroid hormone
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Weight
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
Total body weight
At baseline and 3, 6, 9 and 12 months after enrolment
Skinfold thickness
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum total protein
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum albumin
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Serum prealbumin
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Body mass index
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
At baseline and 3, 6, 9 and 12 months after enrolment
Subjective Global Assessment
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
Final result/score to be reported
At baseline and 3, 6, 9 and 12 months after enrolment
Decline in eGFR
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Worsening of CKD stage
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Start of dialysis
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Presence of a 50% reduction in eGFR
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Serum bicarbonate
Time Frame: At baseline and 3, 6 and 12 months after enrolment
At baseline and 3, 6 and 12 months after enrolment
Serum haemoglobin
Time Frame: At baseline and 3, 6 and 12 months after enrolment
At baseline and 3, 6 and 12 months after enrolment
Serum potassium
Time Frame: At baseline and 3, 6 and 12 months after enrolment
At baseline and 3, 6 and 12 months after enrolment
Reported nausea and vomiting
Time Frame: At baseline and 3, 6 and 12 months after enrolment
At baseline and 3, 6 and 12 months after enrolment
Presence of concomitant disease
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Administration of concomitant medication
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator
Time Frame: Monthly starting at 1 month after enrolment for up to 12 months
Monthly starting at 1 month after enrolment for up to 12 months
Acceptance of diet as documented in the patient diary
Time Frame: Daily for up to 12 months
Daily for up to 12 months
Appetite change as documented in the patient diary
Time Frame: Daily for up to 12 months
Daily for up to 12 months
Change of food intake as documented in the patient diary
Time Frame: Daily for up to 12 months
Daily for up to 12 months
Adverse events including adverse drug reactions and serious adverse events
Time Frame: At 3, 6, 9 and 12 months after enrolment
At 3, 6, 9 and 12 months after enrolment
Blood pressure
Time Frame: At baseline and 3, 6, 9 and at 12 months after enrolment
At baseline and 3, 6, 9 and at 12 months after enrolment
Heart rate
Time Frame: At baseline and 3, 6, 9 and at 12 months after enrolment
At baseline and 3, 6, 9 and at 12 months after enrolment
Body temperature
Time Frame: At baseline and 3, 6, 9 and at 12 months after enrolment
At baseline and 3, 6, 9 and at 12 months after enrolment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Kabi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gábor Zakar, MD, Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Keto-023-CNI

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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