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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • 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
        • Universitätsklinikum Bonn
      • Cologne, Germany
        • Universitatsklinikum Koln
      • 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

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
Intervention / Treatment
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

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

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

Vitaflo International, Ltd

Investigators

  • 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)

January 6, 2017

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimated)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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