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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02825784
Other study ID # NA-REN-072013-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2017
Est. completion date October 31, 2019

Study information

Verified date February 2024
Source Vitaflo International, Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 10 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Germany Universitatsklinikum Bonn Bonn
Germany Universitatsklinikum Koln Cologne
Germany Universitatsklinikum Essen Essen

Sponsors (1)

Lead Sponsor Collaborator
Vitaflo International, Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in serum potassium level To evaluate the nutritional suitability of Renastart, specifically in relation to management of hyperkalemia via blood tests Baseline, week 8, week 16
Secondary Change in height (cm) To monitor the maintenance / improvement of growth over the course of the study. Baseline, week 8, week 16
Secondary Change in mass (kg) To monitor the maintenance / improvement of growth over the course of the study. Baseline, week 8, week 16
Secondary Palatability To evaluate the palatability of Renastart when taken orally via a patient questionnaire. Throughout the 16 weeks
Secondary Gastrointestinal tolerance To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire. Throughout the 16 weeks
Secondary Compliance To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire. Throughout the 16 weeks
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