Study of FFI-1010 in Pediatric Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Children Under 18 Years Old With Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FFI-1010

Group Type EXPERIMENTAL

FFI-1010

Intervention Type DRUG

Intravenous single dosing

Interventions

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FFI-1010

Intravenous single dosing

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No