Skip to main content
OpenTrials
Completed

NCT Number: NCT03345316

Study of FFI-1010 in Pediatric Kidney Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Children Under 18 Years Old With Kidney Disease

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fuji Yakuhin Investigational sites

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FFI-1010

Drug

Intravenous single dosing

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.