Back to resultsStudy of FFI-1010 in Pediatric Kidney Disease
Primary Purpose
Children Under 18 Years Old With Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FFI-1010
Sponsored by
About this trial
This is an interventional diagnostic trial for Children Under 18 Years Old With Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Kidney disease patients requiring exact evaluation of kidney function
- eGFR: >=30 and <=89 mL/min/1.73m^2
Exclusion Criteria:
- Edema on the day before start of study treatment
- Oliguria on the day before start of study treatment
- Dehydration on the day before start of study treatment
- Infection or inflammatory disease before administration
- History of epilepsy or organic brain disorder
- History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease
Sites / Locations
- Fuji Yakuhin Investigational sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FFI-1010
Arm Description
Outcomes
Primary Outcome Measures
Ratio of Cin to Ccr measuring at the same time
Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 administration
Secondary Outcome Measures
Full Information
NCT ID
NCT03345316
First Posted
November 13, 2017
Last Updated
December 10, 2019
Sponsor
Fuji Yakuhin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03345316
Brief Title
Study of FFI-1010 in Pediatric Kidney Disease
Official Title
Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuji Yakuhin Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children Under 18 Years Old With Kidney Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FFI-1010
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FFI-1010
Intervention Description
Intravenous single dosing
Primary Outcome Measure Information:
Title
Ratio of Cin to Ccr measuring at the same time
Description
Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 administration
Time Frame
120 minutes
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Kidney disease patients requiring exact evaluation of kidney function
eGFR: >=30 and <=89 mL/min/1.73m^2
Exclusion Criteria:
Edema on the day before start of study treatment
Oliguria on the day before start of study treatment
Dehydration on the day before start of study treatment
Infection or inflammatory disease before administration
History of epilepsy or organic brain disorder
History of, clinically significant cardiac, hematologic, hepatic and pancreatic disease
Facility Information:
Facility Name
Fuji Yakuhin Investigational sites
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34562149
Citation
Uemura O, Ishikura K, Kamei K, Hamada R, Yamamoto M, Gotoh Y, Fujita N, Sakai T, Sano T, Fushimi M, Iijima K. Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin. Clin Exp Nephrol. 2022 Feb;26(2):132-139. doi: 10.1007/s10157-021-02133-5. Epub 2021 Sep 25.
Results Reference
derived
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Study of FFI-1010 in Pediatric Kidney Disease
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