Status:
COMPLETED
Study of FFI-1010 in Pediatric Kidney Disease
Lead Sponsor:
Fuji Yakuhin Co., Ltd.
Conditions:
Children Under 18 Years Old With Kidney Disease
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Kidney disease patients requiring exact evaluation of kidney function
- eGFR: \>=30 and \<=89 mL/min/1.73m\^2
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03345316
Start Date
November 1 2017
End Date
November 1 2019
Last Update
December 11 2019
Active Locations (1)
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1
Fuji Yakuhin Investigational sites
Tokyo, Japan