Study of FFI-1010 in Pediatric Kidney Disease

Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).

NCT03345316•Fuji Yakuhin Co., Ltd.

View on ClinicalTrials.gov

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

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Fuji Yakuhin Investigational sites

Tokyo, Japan

Key Dates

Start Date

November 1, 2017

Primary Completion Date

November 1, 2019

Completion Date

November 1, 2019

Last Updated

December 11, 2019

Enrollment

ACTUAL participants

Conditions

Children Under 18 Years Old With Kidney Disease

Interventions

FFI-1010

DRUG