Ignite Creation Date:
2024-05-06 @ 8:48 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02825784
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2016-06-17
Brief Title:
A Multicenter Study to Evaluate the Nutritional Suitability of Renastart
Sponsor:
Vitaflo International Ltd
Organization:
Vitaflo International Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Renastart
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None