Chronic Kidney Disease Clinical Trial
— RenastartOfficial 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
Verified date | February 2024 |
Source | Vitaflo International, Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Universitatsklinikum Bonn | Bonn | |
Germany | Universitatsklinikum Koln | Cologne | |
Germany | Universitatsklinikum Essen | Essen |
Lead Sponsor | Collaborator |
---|---|
Vitaflo International, Ltd |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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