Chronic Kidney DiseasesRenastepNCT03602937
Evaluation of Renastep
A study testing Renastep in people with Chronic Kidney Diseases and Renal Disease, run by Vitaflo International, Ltd at 3 sites in United Kingdom.
Trial summary
Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease. Participants will incorporate Renastep into their renal specific diet, during which time they will record gastrointestinal symptoms, adherence to… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Chronic Kidney Diseases, Renal Disease
- What is being tested?
- Renastep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 17 Apr 2018to 1 Dec 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Chronic Kidney Disease.
- Aged between 3 and 18 years.
- Has a requirement for a restricted potassium and/or restricted phosphorus diet.
- Has a requirement for nutrition support.
- Freely given, written, informed consent from patient or parent/guardian.
- Freely given, written assent (if appropriate).
Who cannot join
- Inability to comply with the study protocol, in the opinion of the investigator.
- Aged under 3 years or over 18 years.
- Use of additional enteral feeds during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
- Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Birmingham Children's Hospital
Birmingham, West Midlands, B4 6NH
Alder Hey Children's Hospital
Liverpool, Merseyside, L12 2AP
Southampton Children's Hospital
Southampton, Hampshire, S016 6YD
About this study
Official title: A Study to Evaluate the Acceptability and Nutritional Suitability of Renastep, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Patients From 3-18 Years of Age With Chronic Kidney Disease (CKD)
Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease. Participants will incorporate Renastep into their renal specific diet, during which time they will record gastrointestinal symptoms, adherence to recommended intakes and thoughts on its palatability. A Baseline CRF completed by the Investigator at the start of the trial will record demographic information, GI history and the most recent renal bio-marker results. Bio-marker results recorded as part of routine care over the course of the study will be captured in the End of Study CRF.
The study is designed to generate acceptability data that will be used to support an application to the Advisory Committee on Borderline Substances for Renastep to be reimbursable on prescription within the NHS.
Read the detailed description
Renastep is designed for use in the dietary management of kidney disease between 3 and 18 years of age. It is a high-energy liquid feed containing protein, carbohydrate, fat, vitamins, minerals, trace elements and DHA. It contains low levels of potassium, phosphorus, calcium, chloride and vitamin A compared with a standard paediatric enteral feed.
Vitaflo (International) Ltd has developed Renastep following a request from the Paediatric Renal Interest Nutrition Group (PRING). They requested a low potassium and phosphate, high energy liquid feed for the dietary management of children with kidney disease that can be used as a sip feed or as a part of a modular tube feed.
There is currently no product designed specifically for use in this age group. Current dietetic practice involves either prescribing a powdered infant formula, in variable concentrations, or manipulating an adult renal sip feed to construct a modular feed, meeting the particular individual requirements of a paediatric patient with chronic kidney disease. This can be time consuming, complicated, can frequently involve preparation error leading to over or underconcentration of key nutrients, and increases the risk of microbial contamination. As Renastep is a ready to use product designed specifically for children with kidney disease, it can be expected that it will be more easily incorporated into the dietary management of the patient than the current options available. This has also been requested by the children and their families. Renastep could replace unsafe current practices that are the only option available to clinicians.
In order for Renastep to be prescribed within the NHS, it must first be subject to an application to the Advisory Committee on Borderline Substances (ACBS). The ACBS require data on the product's acceptability, in terms of gastrointestinal tolerance, palatability and participants' adherence to recommended intakes. The ACBS require such acceptability studies to be conducted in at least 15 patients for whom the product is designed. This stipulation is the reason for conducting the trial within patients aged 3 - 18 years of age with Chronic Kidney Disease.
The study will last for 28 days. Participants will self-report study data in Daily Diary forms that include 7 days of gastrointestinal data, daily records of how much of the product has been taken compared to the amount prescribed and a final evaluation of the product's palatability. The investigator will complete a Baseline CRF at the first visit to record demographic information, GI history and the most recent urea, phosphorus and potassium results. This will be supplemented by an End of Study CRF which will record urea, phosphorus and potassium results recorded during the trial period as part of usual clinical care. Information relating to gastrointestinal tolerance of Renastep over the 28-day study period will also be recorded by the Investigator in the End of Study CRF.
All study data will be anonymised and reviewed by the local investigator prior to it being forwarded to the sponsor, Vitaflo (International) Ltd.
- Conditions
- Chronic Kidney Diseases, Renal Disease
- Being tested
- Renastep
- Keywords
- Acceptability, Renal, CKD, Kidney, Vitaflo, High energy, low volume, Low potassium, Low phosphorus, Low vitamin A
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenastepDietary supplement
Renastep is a ready-to-use, high energy, low volume liquid renal specific feed that can be administered enterally via tube or oral consumption.
| Study group | Role | What they receive |
|---|---|---|
| Renastep | Experimental | All participants to incorporate Renastep into their usual dietary regime. Receives: Dietary Supplement: Renastep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' compliance with recommended intakes of Renastep.
Actual intake of the product will be compared with recommended intake. Participant to record how much of the product they took on each of the study days in a daily study dairy.
Measured: Days 1 - 28.
Patients' gastrointestinal tolerance of Renastep.
Participant to record any gastrointestinal symptoms experienced in a daily study diary.
Measured: Days 1 - 7.
Patients' thoughts on Renastep's palatability
Participants will rate Renastep's appearance, smell, taste, aftertaste, texture and presentation on a 5-point Likert scale at the end of their time on the study.
Measured: Day 28.
Patients' thoughts on Renastep's ease of use
Participants will rate Renastep's ease of use on a 5-point likert scale at the end of their time on the study.
Measured: Day 28.
Nutritional suitability
The product's nutritional suitability for use in a renal specific diet will be measured. The investigator will record the participant's most recent urea, phosphorus and potassium results (all mmo/L) taken as part of routine care prior to the intervention period beginning and all available results recorded as part of routine care over the course of the intervention period.
Measured: Days 0 - 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start17 Apr 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label prospective acceptability study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Anderson, Study director, University Hospital Southampton NHS Foundation TrustAlison Holmes, Principal investigator, Alder Hey Children's NHS Foundation TrustSara Janes, Principal investigator, Birmingham Women's and Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602937
- Sponsor's protocol ID
- MCT-RENS-2017-11-07
- Acronym
- Renastep
- Status last verified
- Feb 2024
- First submitted
- 23 Apr 2018
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
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 Study to Evaluate the Acceptability and Nutritional Suitability of Renastep, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Patients From 3-18 Years of Age With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT03602937
- Acronym / sponsor ID
- Renastep / MCT-RENS-2017-11-07
- Conditions
- Chronic Kidney Diseases, Renal Disease
- Keywords
- Acceptability, Renal, CKD, Kidney, Vitaflo, High energy, low volume, Low potassium, Low phosphorus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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.
Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease. Participants will incorporate Renastep into their renal specific diet, during which time they will record gastrointestinal symptoms, adherence to recommended intakes and thoughts on its palatability. A Baseline CRF completed by the Investigator at the start of the trial will record demographic information, GI history and the most recent renal bio-marker results. Bio-marker results recorded as part of routine care over the course of the study will be captured in the End of Study CRF.
The study is designed to generate acceptability data that will be used to support an application to the Advisory Committee on Borderline Substances for Renastep to be reimbursable on prescription within the NHS.
Detailed description
Renastep is designed for use in the dietary management of kidney disease between 3 and 18 years of age. It is a high-energy liquid feed containing protein, carbohydrate, fat, vitamins, minerals, trace elements and DHA. It contains low levels of potassium, phosphorus, calcium, chloride and vitamin A compared with a standard paediatric enteral feed.
Vitaflo (International) Ltd has developed Renastep following a request from the Paediatric Renal Interest Nutrition Group (PRING). They requested a low potassium and phosphate, high energy liquid feed for the dietary management of children with kidney disease that can be used as a sip feed or as a part of a modular tube feed.
There is currently no product designed specifically for use in this age group. Current dietetic practice involves either prescribing a powdered infant formula, in variable concentrations, or manipulating an adult renal sip feed to construct a modular feed, meeting the particular individual requirements of a paediatric patient with chronic kidney disease. This can be time consuming, complicated, can frequently involve preparation error leading to over or underconcentration of key nutrients, and increases the risk of microbial contamination. As Renastep is a ready to use product designed specifically for children with kidney disease, it can be expected that it will be more easily incorporated into the dietary management of the patient than the current options available. This has also been requested by the children and their families. Renastep could replace unsafe current practices that are the only option available to clinicians.
In order for Renastep to be prescribed within the NHS, it must first be subject to an application to the Advisory Committee on Borderline Substances (ACBS). The ACBS require data on the product's acceptability, in terms of gastrointestinal tolerance, palatability and participants' adherence to recommended intakes. The ACBS require such acceptability studies to be conducted in at least 15 patients for whom the product is designed. This stipulation is the reason for conducting the trial within patients aged 3 - 18 years of age with Chronic Kidney Disease.
The study will last for 28 days. Participants will self-report study data in Daily Diary forms that include 7 days of gastrointestinal data, daily records of how much of the product has been taken compared to the amount prescribed and a final evaluation of the product's palatability. The investigator will complete a Baseline CRF at the first visit to record demographic information, GI history and the most recent urea, phosphorus and potassium results. This will be supplemented by an End of Study CRF which will record urea, phosphorus and potassium results recorded during the trial period as part of usual clinical care. Information relating to gastrointestinal tolerance of Renastep over the 28-day study period will also be recorded by the Investigator in the End of Study CRF.
All study data will be anonymised and reviewed by the local investigator prior to it being forwarded to the sponsor, Vitaflo (International) Ltd.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label prospective acceptability study.
| Arm | Type | Receives |
|---|---|---|
| Renastep | Experimental | Dietary Supplement: RenastepAll participants to incorporate Renastep into their usual dietary regime. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of Chronic Kidney Disease.
- Aged between 3 and 18 years.
- Has a requirement for a restricted potassium and/or restricted phosphorus diet.
- Has a requirement for nutrition support.
- Freely given, written, informed consent from patient or parent/guardian.
Key exclusion criteria (4 listed)
- Inability to comply with the study protocol, in the opinion of the investigator.
- Aged under 3 years or over 18 years.
- Use of additional enteral feeds during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
- Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.
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 |
|---|---|---|
| RenastepRenastep is a ready-to-use, high energy, low volume liquid renal specific feed that can be administered enterally via tube or oral consumption. | Dietary supplement | Renastep |
Primary outcome
Patients' compliance with recommended intakes of Renastep.
Time frame: Days 1 - 28.
Actual intake of the product will be compared with recommended intake. Participant to record how much of the product they took on each of the study days in a daily study dairy.
Patients' gastrointestinal tolerance of Renastep.
Time frame: Days 1 - 7.
Participant to record any gastrointestinal symptoms experienced in a daily study diary.
Patients' thoughts on Renastep's palatability
Time frame: Day 28.
Participants will rate Renastep's appearance, smell, taste, aftertaste, texture and presentation on a 5-point Likert scale at the end of their time on the study.
Patients' thoughts on Renastep's ease of use
Time frame: Day 28.
Participants will rate Renastep's ease of use on a 5-point likert scale at the end of their time on the study.
Nutritional suitability
Time frame: Days 0 - 28
The product's nutritional suitability for use in a renal specific diet will be measured. The investigator will record the participant's most recent urea, phosphorus and potassium results (all mmo/L) taken as part of routine care prior to the intervention period beginning and all available results recorded as part of routine care over the course of the intervention period.
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. Individual participant data will not be shared.
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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.
Caroline Anderson study director
University Hospital Southampton NHS Foundation Trust
Alison Holmes principal investigator
Alder Hey Children's NHS Foundation Trust
Sara Janes principal investigator
Birmingham Women's and Children's NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renastep in people with Chronic Kidney Diseases and Renal Disease, run by Vitaflo International, Ltd at 3 sites in United Kingdom.
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 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 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 United Kingdom. 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?
Patients' compliance with recommended intakes of Renastep. (time frame: Days 1 - 28.). The study lists 5 primary outcomes in all. 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.