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

Primary Purpose

Chronic Kidney Disease, Hyperkalemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Renastart
Sponsored by
Vitaflo International, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring potassium chronic kidney disease CKD children

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitatsklinikum Bonn
  • Universitatsklinikum Koln
  • Universitatsklinikum Essen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renastart

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in serum potassium level
To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests

Secondary Outcome Measures

Change in height (cm)
To monitor the maintenance / improvement of growth over the course of the study.
Change in mass (kg)
To monitor the maintenance / improvement of growth over the course of the study.
Palatability
To evaluate the palatability of Renastart when taken orally via a patient questionnaire.
Gastrointestinal tolerance
To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire.
Compliance
To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.

Full Information

First Posted
June 17, 2016
Last Updated
June 10, 2020
Sponsor
Vitaflo International, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02825784
Brief Title
A Multicenter Study to Evaluate the Nutritional Suitability of Renastart
Acronym
Renastart
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitaflo International, Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hyperkalemia
Keywords
potassium chronic kidney disease CKD children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renastart
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Renastart
Intervention Description
Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
Primary Outcome Measure Information:
Title
Change in serum potassium level
Description
To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests
Time Frame
Baseline, week 8, week 16
Secondary Outcome Measure Information:
Title
Change in height (cm)
Description
To monitor the maintenance / improvement of growth over the course of the study.
Time Frame
Baseline, week 8, week 16
Title
Change in mass (kg)
Description
To monitor the maintenance / improvement of growth over the course of the study.
Time Frame
Baseline, week 8, week 16
Title
Palatability
Description
To evaluate the palatability of Renastart when taken orally via a patient questionnaire.
Time Frame
Throughout the 16 weeks
Title
Gastrointestinal tolerance
Description
To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire.
Time Frame
Throughout the 16 weeks
Title
Compliance
Description
To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.
Time Frame
Throughout the 16 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Hoppe
Organizational Affiliation
Universitätsklinik Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitatsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Cologne
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Multicenter Study to Evaluate the Nutritional Suitability of Renastart

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