Evaluation of Renastep (Renastep)

February 15, 2024 updated by: Vitaflo International, Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, S016 6YD
        • Southampton Children's Hospital
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Birmingham Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

i) Diagnosis of Chronic Kidney Disease.

ii) Aged between 3 and 18 years.

iii) Has a requirement for a restricted potassium and/or restricted phosphorus diet.

iv) Has a requirement for nutrition support.

v) Freely given, written, informed consent from patient or parent/guardian.

vi) Freely given, written assent (if appropriate).

Exclusion Criteria:

i) Inability to comply with the study protocol, in the opinion of the investigator.

ii) Aged under 3 years or over 18 years.

iii) 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).

iv) Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Renastep
All participants to incorporate Renastep into their usual dietary regime.
Dietary supplement: Renastep
Renastep is a ready-to-use, high energy, low volume liquid renal specific feed that can be administered enterally via tube or oral consumption.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Days 1 - 28.
Patients' gastrointestinal tolerance of Renastep.
Time Frame: Days 1 - 7.
Participant to record any gastrointestinal symptoms experienced in a daily study diary.
Days 1 - 7.
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.
Day 28.
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.
Day 28.
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.
Days 0 - 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vitaflo International, Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Caroline Anderson, University Hospital Southampton NHS Foundation Trust
  • Principal Investigator: Alison Holmes, Alder Hey Children's NHS Foundation Trust
  • Principal Investigator: Sara Janes, Birmingham Women's and Children's NHS Foundation Trust

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCT-RENS-2017-11-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Chronic Kidney Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings