Chronic Kidney DiseaseRenastartNCT02825784
A Multicenter Study to Evaluate the Nutritional Suitability of Renastart
A study testing Renastart in people with Chronic Kidney Disease and Hyperkalemia, run by Vitaflo International, Ltd at 3 sites in Germany.
Trial summary
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD) Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Chronic Kidney Disease, Hyperkalemia
- What is being tested?
- Renastart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesGermany
- Study dates
- 6 Jan 2017to 31 Oct 2019
- Phase
- Interventional
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 10 years or under at the time of enrolment into the study.
- Diagnosed with Chronic Kidney Disease
- Requirement for a low potassium diet, as evidence by elevated serum potassium levels (> normal reference value which is 3.5-5.0 mmol/L)
- Requirement for a low potassium enteral formula to provide a minimum of 20% of daily energy (kcal) requirements. (calculated according to individual child's needs and according to local clinical practice)
- Written informed consent provided by parent/primary caregiver.
- Assent provided by child, if appropriate.
Who cannot join
- Receiving total parenteral nutrition (TPN).
- Intolerance or allergy to cow's milk or any other ingredients in Renastart.
- Prior intolerance of Renastart formula.
- Any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption.
- Liver failure.
- Active infection or presenting with any signs or symptoms of an infectious disease at screening.
- Concurrent enrollment into another clinical trial.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Universitatsklinikum Bonn
Bonn
Universitatsklinikum Koln
Cologne
Universitatsklinikum Essen
Essen
About this study
Official title: A Multicenter, Open Label, Uncontrolled Study to Evaluate the Acceptability, Tolerability and Nutritional Suitability of Renastart: Specially Formulated to Meet the Unique Nutritional Needs From Birth to 10 Years With Chronic Kidney Disease
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD)
Read the detailed description
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD)
Primary Objective To investigate the nutritional suitability of Renastart in children aged 10 years and under with CKD, particularly with respect to the dietary management of hyperkalemia and the maintenance / improvement of growth.
Secondary Objectives To investigate the acceptance, compliance, palatability, and tolerance of Renastart in children aged under 10 years with CKD.
A total of 15 children with CKD will be enrolled in the study.
- Conditions
- Chronic Kidney Disease, Hyperkalemia
- Being tested
- Renastart
- Keywords
- potassium chronic kidney disease CKD children
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenastartDietary supplement
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
| Study group | Role | What they receive |
|---|---|---|
| Renastart | Experimental | Compared to cows' milk and/or standard pediatric enteral feeds, Renastart has the following additional nutritional features that are beneficial in children with CKD: lower phosphorus, calcium and vitamin A. The powder presentation allows flexibility with dilutions to facilitate the provision of adequate energy and protein to support growth in children with CKD.
For each subject, the recommended daily intake of Renastart is determined by the dietitian in collaboration with the local PI and primary nephrologist based on individual nutritional requirements, specifically dietary intake of potassium and serum potassium levels.
Renastart is to be given by the clinician and based on clinical and nutritional needs. Standard preparation guidelines can be found on the Renastart label. Receives: Dietary Supplement: Renastart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum potassium level
To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests
Measured: Baseline, week 8, week 16
Secondary outcomes (5)
Change in height (cm)
To monitor the maintenance / improvement of growth over the course of the study.
Measured: Baseline, week 8, week 16
Change in mass (kg)
To monitor the maintenance / improvement of growth over the course of the study.
Measured: Baseline, week 8, week 16
Palatability
To evaluate the palatability of Renastart when taken orally via a patient questionnaire.
Measured: Throughout the 16 weeks
Gastrointestinal tolerance
To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire.
Measured: Throughout the 16 weeks
Compliance
To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.
Measured: Throughout the 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start6 Jan 2017
- Primary completion31 May 2019
- Study completion31 Oct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernd Hoppe, Principal investigator, Universitätsklinik Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825784
- Sponsor's protocol ID
- NA-REN-072013-03
- Acronym
- Renastart
- Status last verified
- Feb 2024
- First submitted
- 17 Jun 2016
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Uncontrolled Study to Evaluate the Acceptability, Tolerability and Nutritional Suitability of Renastart: Specially Formulated to Meet the Unique Nutritional Needs From Birth to 10 Years With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02825784
- Acronym / sponsor ID
- Renastart / NA-REN-072013-03
- Conditions
- Chronic Kidney Disease, Hyperkalemia
- Keywords
- potassium chronic kidney disease CKD children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 7 Jul 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.
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD)
Detailed description
A multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (Renastart, Vitaflo International Ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD)
Primary Objective To investigate the nutritional suitability of Renastart in children aged 10 years and under with CKD, particularly with respect to the dietary management of hyperkalemia and the maintenance / improvement of growth.
Secondary Objectives To investigate the acceptance, compliance, palatability, and tolerance of Renastart in children aged under 10 years with CKD.
A total of 15 children with CKD will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renastart | Experimental | Dietary Supplement: RenastartCompared to cows' milk and/or standard pediatric enteral feeds, Renastart has the following additional nutritional features that are beneficial in children with CKD: lower phosphorus, calcium and vitamin A. The powder presentation allows flexibility with dilutions to facilitate the provision of adequate energy and protein to support growth in children with CKD. For each subject, the recommended daily intake of Renastart is determined by the dietitian in collaboration with the local PI and primary nephrologist based on individual nutritional requirements, specifically dietary intake of potassium and serum potassium levels. Renastart is to be given by the clinician and based on clinical and nutritional needs. Standard preparation guidelines can be found on the Renastart label. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 10 years or under at the time of enrolment into the study.
- Diagnosed with Chronic Kidney Disease
- Requirement for a low potassium diet, as evidence by elevated serum potassium levels (> normal reference value which is 3.5-5.0 mmol/L)
- Requirement for a low potassium enteral formula to provide a minimum of 20% of daily energy (kcal) requirements. (calculated according to individual child's needs and according to local clinical practice)
- Written informed consent provided by parent/primary caregiver.
Key exclusion criteria (7 listed)
- Receiving total parenteral nutrition (TPN).
- Intolerance or allergy to cow's milk or any other ingredients in Renastart.
- Prior intolerance of Renastart formula.
- Any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption.
- Liver failure.
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 |
|---|---|---|
| RenastartRenastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD). | Dietary supplement | Renastart |
Primary outcome
Change in serum potassium level
Time frame: Baseline, week 8, week 16
To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests
5 secondary outcomes
Change in height (cm)
Time frame: Baseline, week 8, week 16
Change in mass (kg)
Time frame: Baseline, week 8, week 16
Palatability
Time frame: Throughout the 16 weeks
Gastrointestinal tolerance
Time frame: Throughout the 16 weeks
Compliance
Time frame: Throughout the 16 weeks
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 16 Feb 2024.
- 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.
Bernd Hoppe principal investigator
Universitätsklinik Bonn
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renastart in people with Chronic Kidney Disease and Hyperkalemia, run by Vitaflo International, Ltd at 3 sites in Germany.
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 6 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 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Change in serum potassium level (time frame: Baseline, week 8, week 16). 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 16 Feb 2024.