Chronic Kidney DiseaseNCT02746133
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)
An observational study of Chronic Kidney Disease, run by Fresenius Kabi at 2 sites in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Observational study: Supplemented protein-restricted diet
- How many people
- 85 participants
- Where
- 2 sitesRussia
- Study dates
- 25 Jul 2016to 14 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in Russia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Observational study: Supplemented protein-restricted diet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study: Supplemented protein-restricted dietOther
Observational study: Supplemented protein-restricted diet
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease (pre-dialysis) | Observational study: Supplemented protein-restricted diet Receives: Other: Observational study: Supplemented protein-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance to Ketosteril (number of tablets taken; patient reported)
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.
Patient compliance to Ketosteril will be assessed daily, for a total of 12 months.
Measured: 12 months
Secondary outcomes (45)
Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary)
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.
Measured: Monthly, starting 1 month after enrolment, for a total of 12 months
CKD stage (according to KDIGO guideline)
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Presence of comorbidities
Measured: At baseline
Serum creatinine
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
24h urinary protein
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Urinary microalbumin
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum urea
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Creatinine clearance
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Glomerular filtration rate (GFR)
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Estimated GFR [eGFR]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Fasting blood glucose
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Fasting plasma glucose
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Haemoglobin A1c [HbA1c]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum triglyceride
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum cholesterol
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum high-density lipoprotein [HDL]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum low-density lipoprotein [LDL]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum calcium
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum phosphate
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum parathyroid hormone [PTH]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Body weight
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Skinfold thickness
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum total protein
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum albumin
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum prealbumin
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Body mass index [BMI]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Subjective global assessment [SGA]
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Decline in eGFR
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Worsening of CKD stage
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Start of dialysis
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Presence of a 50% reduction in eGFR
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum bicarbonate
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum haemoglobin
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Serum potassium
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Reported nausea and vomiting
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Presence of concomitant disease
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Administration of concomitant medication
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator
Measured: Monthly, starting at 1 month after enrolment for up to 12 months
Acceptance of diet as documented in the patient diary
Measured: Daily, for up to 12 months
Appetite change as documented in the patient diary
Measured: Daily, for up to 12 months
Change of food intake as documented in the patient diary
Measured: Daily, for up to 12 months
Adverse events including adverse drug reactions and serious adverse events
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Blood pressure
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Heart rate
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Body temperature
Measured: At baseline and 3, 6, 9 and 12 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start25 Jul 2016
- Primary completion28 Dec 2018
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aleksander Y. Zemchenkov, MD, Principal investigator, St. Petersburg State Budgetary Healthcare Institution "Mariinskaya City Hospital",
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746133
- Sponsor's protocol ID
- Keto-027-CNI
- Status last verified
- Jan 2019
- First submitted
- 6 Apr 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02746133
- Acronym / sponsor ID
- Keto-027-CNI
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease (pre-dialysis) | – | Other: Observational study: Supplemented protein-restricted dietObservational study: Supplemented protein-restricted diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in Russia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study: Supplemented protein-restricted dietObservational study: Supplemented protein-restricted diet | Other | Chronic kidney disease (pre-dialysis) |
Primary outcome
Patient compliance to Ketosteril (number of tablets taken; patient reported)
Time frame: 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. Patient compliance to Ketosteril will be assessed daily, for a total of 12 months.
45 secondary outcomes
Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary)
Time frame: 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
Presence of comorbidities
Time frame: At baseline
Serum creatinine
Time frame: 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
Urinary microalbumin
Time frame: 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
Creatinine clearance
Time frame: 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
Estimated GFR [eGFR]
Time frame: 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
Fasting plasma glucose
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Haemoglobin A1c [HbA1c]
Time frame: 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
Serum cholesterol
Time frame: 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
Serum low-density lipoprotein [LDL]
Time frame: 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
Serum phosphate
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum parathyroid hormone [PTH]
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Body weight
Time frame: 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
Serum total protein
Time frame: 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
Serum prealbumin
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Body mass index [BMI]
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Subjective global assessment [SGA]
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Decline in eGFR
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Worsening of CKD stage
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Start of dialysis
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Presence of a 50% reduction in eGFR
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum bicarbonate
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum haemoglobin
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Serum potassium
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Reported nausea and vomiting
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Presence of concomitant disease
Time frame: At baseline and 3, 6, 9 and 12 months after enrolment
Administration of concomitant medication
Time frame: At baseline and 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
Acceptance of diet as documented in the patient diary
Time frame: Daily, for up to 12 months
Appetite change as documented in the patient diary
Time frame: Daily, for up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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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.
Aleksander Y. Zemchenkov, MD principal investigator
St. Petersburg State Budgetary Healthcare Institution "Mariinskaya City Hospital",
2 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 Disease, run by Fresenius Kabi at 2 sites in Russia.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance to Ketosteril (number of tablets taken; patient reported) (time frame: 12 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 1 Feb 2019.