NCT03345316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

November 13, 2017

Last Update Submit

December 10, 2019

Conditions

Children Under 18 Years Old With Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Ratio of Cin to Ccr measuring at the same time

    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

Study Arms (1)

FFI-1010

EXPERIMENTAL
Drug: FFI-1010

Interventions

FFI-1010DRUG

Intravenous single dosing

FFI-1010

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Kidney disease patients requiring exact evaluation of kidney function
  • eGFR: \>=30 and \<=89 mL/min/1.73m\^2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuji Yakuhin Investigational sites

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 34562149DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

JP(1)