Study of FFI-1010 in Pediatric Kidney Disease

December 10, 2019 updated by: Fuji Yakuhin Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Fuji Yakuhin Investigational sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FFI-1010
Drug: FFI-1010
Intravenous single dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of Cin to Ccr measuring at the same time
Time Frame: 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
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuji Yakuhin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFI-1010-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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