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

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ClinicalTrials.gov Identifier: NCT02825784
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Vitaflo International, Ltd

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)

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperkalemia Dietary Supplement: Renastart Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 6, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in height (cm) [ Time Frame: Baseline, week 8, week 16 ]
    To monitor the maintenance / improvement of growth over the course of the study.

  2. Change in mass (kg) [ Time Frame: Baseline, week 8, week 16 ]
    To monitor the maintenance / improvement of growth over the course of the study.

  3. Palatability [ Time Frame: Throughout the 16 weeks ]
    To evaluate the palatability of Renastart when taken orally via a patient questionnaire.

  4. 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.

  5. 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.



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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825784


Contacts
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Contact: Tom Barker 0151 709 9020 ext 273 TomBarker@Vitaflo.co.uk
Contact: Maura O'Donnell 0151 702 4933 Maura.ODonnell@Vitaflo.co.uk

Locations
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Germany
Universitatsklinikum Bonn Recruiting
Bonn, Germany
Contact: Bernd Hoppe    +49 228 287 33194    Bernd.Hoppe@Ukb.Uni-Bonn.De   
Universitatsklinikum Koln Recruiting
Cologne, Germany
Contact: Christina Taylan    +49 221 478 4319    Christina.Taylan@Uk-Koeln.De   
Universitatsklinikum Essen Recruiting
Essen, Germany
Contact: Rainer Büscher    +49 201 723 2738    Rainer.Buescher@Uk-Essen.De   
Sponsors and Collaborators
Vitaflo International, Ltd
Investigators
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Principal Investigator: Bernd Hoppe Universitätsklinik Bonn

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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02825784     History of Changes
Other Study ID Numbers: NA-REN-072013-03
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Vitaflo International, Ltd:
potassium chronic kidney disease CKD children

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperkalemia
Urologic Diseases
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases