Study of FFI-1010 in Pediatric Kidney Disease

Phase 3

Completed

• Conditions: Children Under 18 Years Old With Kidney Disease
• Interventions: Drug: FFI-1010

• Registration Number: NCT03345316
• Lead Sponsor: Fuji Yakuhin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-17
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FFI-1010	FFI-1010	-

Primary Outcome Measures

Name	Time	Method
Ratio of Cin to Ccr measuring at the same time	120 minutes	Demonstrating usability of inulin clearance by comparison between inulin clearance and creatinine clearance at the same time after the start of FFI-1010 administration

Trial Locations

Locations (1)

Fuji Yakuhin Investigational sites; 🇯🇵 Tokyo, Japan