Chronic Kidney DiseasePhase 4KETOPROGNCT02031224
Supplemented Very Low Protein Diet and the Progression of Chronic Kidney Disease
A Phase 4 study testing Conventional low protein diet and Very low protein diet supplemented with Ketosteril in people with Chronic Kidney Disease, run by Anemia Working Group Romania at 1 site in Romania.
Trial summary
This is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (CKD) in patients with advanced… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Conventional low protein diet and Very low protein diet supplemented with Ketosteril
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2008to Aug 2014
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult non-diabetic patients
- stage 4-5 CKD not on dialysis (estimated glomerular filtration by Modification of Diet in Renal Disease formula < 30 mL/min per year
- stable renal function at least 12 weeks before enrollment
- well-controlled arterial blood pressure
- proteinuria less than 1 g/g urinary creatinine
- good nutritional status
- declared and anticipated good compliance with the prescribed diet
Who cannot join
- poorly controlled arterial blood pressure (≥145/85 mm Hg)
- relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
- uremic complications (pericarditis, polyneuropathy)
- feeding inability (anorexia, nausea)
Trial locations and contacts
1 site in 1 country.
Romania1 site
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, 010731
About this study
Official title: Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease
This is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (CKD) in patients with advanced CKD.
Read the detailed description
All eligible patients who will give informed consent will be screened. Those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional LPD will be prescribed in all patients.
At the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total duration of 15 months.
Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin).
The anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter.
The compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter.
The blood pressure levels, drugs required for the therapy of hypertension, acidosis and mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.
- Conditions
- Chronic Kidney Disease
- Being tested
- Conventional low protein diet, Very low protein diet supplemented with Ketosteril
- Keywords
- Chronic Kidney Disease, Restricted protein diets, Nutritional status
- 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.
Conventional low protein dietBehavioural
Also called LPD, Hypoproteic diet
Very low protein diet supplemented with KetosterilDietary supplement
Also called SVLPD, Keto-diet
| Study group | Role | What they receive |
|---|---|---|
| Keto-diet (KD) | Experimental | Patients in the intervention arm (KD group) will receive a vegetarian very low protein diet (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day. Receives: Dietary Supplement: Very low protein diet supplemented with Ketosteril |
| Low Protein Diet group (LPD) | Active comparator | The patients in the control arm (LPD group) will continue their conventional low protein diet, with 0.6 g/kg per day (including high biological value proteins).
The total recommended energy intake is of 30 kcal/kg of ideal dry body weight per day in both arms. Receives: Behavioral: Conventional low protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary composite endpoint
Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization
Measured: 15 months after randomization
Secondary outcomes (16)
Secondary efficacy parameter
The rate of decline in the estimated Glomerular Filtration Rate
Measured: months 3-15 after randomization
Secondary outcome measure - nitrogen balance
variations in serum urea
Measured: 15 months after randomization
Secondary efficacy parameter - mineral metabolism
variations in total serum calcium
Measured: 15 weeks after randomization
Secondary efficacy parameter
variations in serum phosphate level
Measured: 15 weeks after randomization
Secondary efficacy parameter
variations in serum bicarbonate
Measured: 15 weeks after randomization
Secondary safety parameter
Subjective Global Assessment of the nutritional status
Measured: 18 weeks after enrolment
Secondary safety parameter
Body Mass Index
Measured: 18 weeks after enrolment
Secondary outcome measure - Nutritional status
Tricipital skinfold
Measured: 18 weeks after enrolment
Secondary safety parameter - anthropometric measures
Mid-arm muscular circumference
Measured: 18 weeks after enrolment
Nutritional status - biochemical markers
serum albumin
Measured: 18 weeks after enrolment
Inflammation
serum level of C reactive protein
Measured: 18 weeks after enrolment
Nutritional status - biochemical marker
Serum total cholesterol
Measured: 18 weeks after enrolment
Secondary safety parameter
Serum potassium level
Measured: 18 weeks after enrolment
Secondary safety parameter
liver enzymes: Aspartate Aminotransferase, Alanine Transaminase
Measured: 18 weeks after enrolment
Safety parameter - adverse events
Occurrence of any adverse event
Measured: 18 weeks after enrolment
Secondary safety parameter - withdrawals
number of withdrawals
Measured: 18 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startMar 2008
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anemia Working Group Romania
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Carol Davila Teaching Hospital of Nephrology Bucharest
- Responsible party
- Principal investigator, Liliana Garneata, Carol Davila University of Medicine and Pharmacy
- Investigators
- Gabriel Mircescu, Prof, Study chair, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031224
- Sponsor's protocol ID
- AWG13/2007
- Acronym
- KETOPROG
- Status last verified
- Dec 2017
- First submitted
- 7 Jan 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mircescu G, Garneata L, Stancu SH, Capusa C. Effects of a supplemented hypoproteic diet in chronic kidney disease. J Ren Nutr. 2007 May;17(3):179-88. doi: 10.1053/j.jrn.2006.12.012.
PubMed 17462550Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.
PubMed 33118160
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02031224
- Acronym / sponsor ID
- KETOPROG / AWG13/2007
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Restricted protein diets, Nutritional status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Anemia Working Group RomaniaUniversity, hospital or other
- Collaborators
- Dr Carol Davila Teaching Hospital of Nephrology Bucharest
- Study start
- Mar 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Jan 2014 (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.
This is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (CKD) in patients with advanced CKD.
Detailed description
All eligible patients who will give informed consent will be screened. Those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional LPD will be prescribed in all patients.
At the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total duration of 15 months.
Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin).
The anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter.
The compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter.
The blood pressure levels, drugs required for the therapy of hypertension, acidosis and mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto-diet (KD) | Experimental | Dietary Supplement: Very low protein diet supplemented with KetosterilPatients in the intervention arm (KD group) will receive a vegetarian very low protein diet (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day. |
| Low Protein Diet group (LPD) | Active comparator | Behavioral: Conventional low protein dietThe patients in the control arm (LPD group) will continue their conventional low protein diet, with 0.6 g/kg per day (including high biological value proteins). The total recommended energy intake is of 30 kcal/kg of ideal dry body weight per day in both arms. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult non-diabetic patients
- stage 4-5 CKD not on dialysis (estimated glomerular filtration by Modification of Diet in Renal Disease formula < 30 mL/min per year
- stable renal function at least 12 weeks before enrollment
- well-controlled arterial blood pressure
- proteinuria less than 1 g/g urinary creatinine
Key exclusion criteria (4 listed)
- poorly controlled arterial blood pressure (≥145/85 mm Hg)
- relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
- uremic complications (pericarditis, polyneuropathy)
- feeding inability (anorexia, nausea)
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 |
|---|---|---|
| Conventional low protein dietAlso: LPD, Hypoproteic diet | Behavioural | Low Protein Diet group (LPD) |
| Very low protein diet supplemented with KetosterilAlso: SVLPD, Keto-diet | Dietary supplement | Keto-diet (KD) |
Primary outcome
Primary composite endpoint
Time frame: 15 months after randomization
Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization
16 secondary outcomes
Secondary efficacy parameter
Time frame: months 3-15 after randomization
Secondary outcome measure - nitrogen balance
Time frame: 15 months after randomization
Secondary efficacy parameter - mineral metabolism
Time frame: 15 weeks after randomization
Secondary efficacy parameter
Time frame: 15 weeks after randomization
Secondary efficacy parameter
Time frame: 15 weeks after randomization
Secondary safety parameter
Time frame: 18 weeks after enrolment
Secondary safety parameter
Time frame: 18 weeks after enrolment
Secondary outcome measure - Nutritional status
Time frame: 18 weeks after enrolment
Secondary safety parameter - anthropometric measures
Time frame: 18 weeks after enrolment
Nutritional status - biochemical markers
Time frame: 18 weeks after enrolment
Inflammation
Time frame: 18 weeks after enrolment
Nutritional status - biochemical marker
Time frame: 18 weeks after enrolment
Secondary safety parameter
Time frame: 18 weeks after enrolment
Secondary safety parameter
Time frame: 18 weeks after enrolment
Safety parameter - adverse events
Time frame: 18 weeks after enrolment
Secondary safety parameter - withdrawals
Time frame: 18 weeks after enrolment
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 22 Dec 2017.
- Results publication: PubMed 17462550Mircescu G, Garneata L, Stancu SH, Capusa C. Effects of a supplemented hypoproteic diet in chronic kidney disease. J Ren Nutr. 2007 May;17(3):179-88. doi: 10.1053/j.jrn.2006.12.012.
- Derived from this study: PubMed 33118160Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.
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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.
Gabriel Mircescu, Prof study chair
Carol Davila University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional low protein diet and Very low protein diet supplemented with Ketosteril in people with Chronic Kidney Disease, run by Anemia Working Group Romania at 1 site in Romania.
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 7 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: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary composite endpoint (time frame: 15 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031224, which also lists 2 linked publications.
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 22 Dec 2017.