A Multicenter Study to Evaluate the Nutritional Suitability of Renastart (Renastart)

February 15, 2024 updated by: Vitaflo International, Ltd

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)

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

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 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.
12

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

  • Germany
      • Bonn, Germany
        • Universitatsklinikum Bonn
      • Cologne, Germany
        • Universitätsklinikum Köln
      • Essen, Germany
        • Universitätsklinikum Essen

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

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 10 years or under at the time of enrolment into the study.
  2. Diagnosed with Chronic Kidney Disease
  3. Requirement for a low potassium diet, as evidence by elevated serum potassium levels (> normal reference value which is 3.5-5.0 mmol/L)
  4. 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)
  5. Written informed consent provided by parent/primary caregiver.
  6. Assent provided by child, if appropriate.

Exclusion Criteria:

  1. Receiving total parenteral nutrition (TPN).
  2. Intolerance or allergy to cow's milk or any other ingredients in Renastart.
  3. Prior intolerance of Renastart formula.
  4. Any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption.
  5. Liver failure.
  6. Active infection or presenting with any signs or symptoms of an infectious disease at screening.
  7. Concurrent enrollment into another clinical trial.

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: Treatment
  • 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: Renastart

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.
Dietary supplement: Renastart
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).

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
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
Baseline, week 8, week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in height (cm)
Time Frame: Baseline, week 8, week 16
To monitor the maintenance / improvement of growth over the course of the study.
Baseline, week 8, week 16
Change in mass (kg)
Time Frame: Baseline, week 8, week 16
To monitor the maintenance / improvement of growth over the course of the study.
Baseline, week 8, week 16
Palatability
Time Frame: Throughout the 16 weeks
To evaluate the palatability of Renastart when taken orally via a patient questionnaire.
Throughout the 16 weeks
Gastrointestinal tolerance
Time Frame: Throughout the 16 weeks
To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire.
Throughout the 16 weeks
Compliance
Time Frame: Throughout the 16 weeks
To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.
Throughout the 16 weeks

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.
  • Principal Investigator: Bernd Hoppe, Universitätsklinik Bonn

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.
January 6, 2017

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.
May 31, 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.
October 31, 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).
June 17, 2016

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 1, 2016

First Posted (Estimated)

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 7, 2016

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.
  • NA-REN-072013-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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