Study of FFI-1010 in Pediatric Kidney Disease

Fuji Yakuhin Co., Ltd.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Children Under 18 Years Old With Kidney Disease

Interventions

FFI-1010DRUG

Intravenous single dosing

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 120 minutes

Data from ClinicalTrials.gov

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