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Study of FFI-1010 in Pediatric Kidney Disease

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ClinicalTrials.gov Identifier: NCT03345316
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Fuji Yakuhin Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Children Under 18 Years Old With Kidney Disease Drug: FFI-1010 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: FFI-1010 Drug: FFI-1010
Intravenous single dosing



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345316


Contacts
Contact: Tomomitsu Sasaki +81-48-644-3403 tomomitsu@fujiyakuhin.co.jp

Locations
Japan
Fuji Yakuhin Investigational sites Recruiting
Tokyo, Japan
Sponsors and Collaborators
Fuji Yakuhin Co., Ltd.

Responsible Party: Fuji Yakuhin Co., Ltd.
ClinicalTrials.gov Identifier: NCT03345316     History of Changes
Other Study ID Numbers: FFI-1010-004
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases