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Study of FFI-1010 in Pediatric Kidney Disease

NCT ID: NCT03345316

Last Updated: 2019-12-11

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.

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

Sponsors

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Fuji Yakuhin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuji Yakuhin Investigational sites

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Uemura O, Ishikura K, Kamei K, Hamada R, Yamamoto M, Gotoh Y, Fujita N, Sakai T, Sano T, Fushimi M, Iijima K. Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin. Clin Exp Nephrol. 2022 Feb;26(2):132-139. doi: 10.1007/s10157-021-02133-5. Epub 2021 Sep 25.

Reference Type DERIVED
PMID: 34562149 (View on PubMed)

Other Identifiers

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FFI-1010-004

Identifier Type: -

Identifier Source: org_study_id