- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02649205
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
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Velence, Hungary, 2481
- Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft
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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
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 |
Intervention / Treatment |
---|---|
Chronic kidney disease (pre-dialysis)
Observational study: Supplemented protein-restricted diet
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Observational study: Supplemented protein-restricted diet
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What is the study measuring?
Primary Outcome Measures
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.
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Daily, for a total of 12 months
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Secondary Outcome Measures
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
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At baseline and 3, 6, 9 and 12 months after enrolment
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Presence of comorbidities
Time Frame: At baseline
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e.g., diabetes, hypertension, metabolic syndrome
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At baseline
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Serum creatinine
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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24h urinary protein
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Urinary microalbumin
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum urea
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
|
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Creatinine clearance
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Glomerular filtration rate (GFR)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Estimated glomerular filtration rate (eGFR)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Fasting blood glucose
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Fasting plasma glucose
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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HbA1c
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum triglyceride
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum cholesterol
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum high-density lipoprotein (HDL)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum low-density lipoprotein (LDL)
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum calcium
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum phosphate
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum parathyroid hormone
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Weight
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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Total body weight
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At baseline and 3, 6, 9 and 12 months after enrolment
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Skinfold thickness
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum total protein
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum albumin
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Serum prealbumin
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Body mass index
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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At baseline and 3, 6, 9 and 12 months after enrolment
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Subjective Global Assessment
Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment
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Final result/score to be reported
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At baseline and 3, 6, 9 and 12 months after enrolment
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Decline in eGFR
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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Worsening of CKD stage
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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Start of dialysis
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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Presence of a 50% reduction in eGFR
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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Serum bicarbonate
Time Frame: At baseline and 3, 6 and 12 months after enrolment
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At baseline and 3, 6 and 12 months after enrolment
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Serum haemoglobin
Time Frame: At baseline and 3, 6 and 12 months after enrolment
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At baseline and 3, 6 and 12 months after enrolment
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Serum potassium
Time Frame: At baseline and 3, 6 and 12 months after enrolment
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At baseline and 3, 6 and 12 months after enrolment
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Reported nausea and vomiting
Time Frame: At baseline and 3, 6 and 12 months after enrolment
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At baseline and 3, 6 and 12 months after enrolment
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Presence of concomitant disease
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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Administration of concomitant medication
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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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
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Monthly starting at 1 month after enrolment for up to 12 months
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Acceptance of diet as documented in the patient diary
Time Frame: Daily for up to 12 months
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Daily for up to 12 months
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Appetite change as documented in the patient diary
Time Frame: Daily for up to 12 months
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Daily for up to 12 months
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Change of food intake as documented in the patient diary
Time Frame: Daily for up to 12 months
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Daily for up to 12 months
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Adverse events including adverse drug reactions and serious adverse events
Time Frame: At 3, 6, 9 and 12 months after enrolment
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At 3, 6, 9 and 12 months after enrolment
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Blood pressure
Time Frame: At baseline and 3, 6, 9 and at 12 months after enrolment
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At baseline and 3, 6, 9 and at 12 months after enrolment
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Heart rate
Time Frame: At baseline and 3, 6, 9 and at 12 months after enrolment
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At baseline and 3, 6, 9 and at 12 months after enrolment
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Body temperature
Time Frame: At baseline and 3, 6, 9 and at 12 months after enrolment
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At baseline and 3, 6, 9 and at 12 months after enrolment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
February 1, 2016
Primary Completion (Actual)
October 9, 2018
Study Completion (Actual)
October 9, 2018
Study Registration Dates
First Submitted
December 17, 2015
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimate)
January 7, 2016
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
October 16, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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