A Multicenter Study to Evaluate the Nutritional Suitability of Renastart

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Hyperkalemia
• Interventions: Dietary Supplement: Renastart

• Registration Number: NCT02825784
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Study Start: 2017-01-06
• Primary Completion: 2019-05-31
• Study Completion: 2019-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renastart	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.

Primary Outcome Measures

Name	Time	Method
Change in serum potassium level	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

Name	Time	Method
Change in mass (kg)	Baseline, week 8, week 16	To monitor the maintenance / improvement of growth over the course of the study.
Compliance	Throughout the 16 weeks	To evaluate patient compliance with Renastart administration when taken orally or by enteral feeding tube via a patient questionnaire.
Change in height (cm)	Baseline, week 8, week 16	To monitor the maintenance / improvement of growth over the course of the study.
Gastrointestinal tolerance	Throughout the 16 weeks	To evaluate the GI tolerance of Renastart when taken orally or by enteral feeding tube via a patient questionnaire.
Palatability	Throughout the 16 weeks	To evaluate the palatability of Renastart when taken orally via a patient questionnaire.

Trial Locations

Locations (3)

Universitatsklinikum Bonn; 🇩🇪 Bonn, Germany

Universitatsklinikum Koln; 🇩🇪 Cologne, Germany

Universitatsklinikum Essen; 🇩🇪 Essen, Germany