A Multicenter Study to Evaluate the Nutritional Suitability of Renastart

Chronic Kidney Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825784
• Other study ID #: NA-REN-072013-03
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperkalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

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