Clinical trial NCT02825784: A Multicenter Study to Evaluate the Nutritional Suitability of 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hyperkalemia
Keywords: potassium chronic kidney disease CKD children
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 12
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in serum potassium level
timeFrame: Baseline, week 8, week 16
Secondary outcomes:
measure: Change in height (cm)
timeFrame: Baseline, week 8, week 16
measure: Change in mass (kg)
timeFrame: Baseline, week 8, week 16
measure: Palatability
timeFrame: Throughout the 16 weeks
measure: Gastrointestinal tolerance
timeFrame: Throughout the 16 weeks
measure: Compliance
timeFrame: Throughout the 16 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Cologne
country: Germany
facility: Universitatsklinikum Koln
city: Essen
country: Germany
facility: Universitatsklinikum Essen
Study officials:
affiliation: Universitätsklinik Bonn
name: Bernd Hoppe
role: PRINCIPAL_INVESTIGATOR
References: