Study of FFI-1010 in Pediatric Kidney Disease

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03345316

Enrollment

Registered

2017-11-17

Start date

2017-11-01

Completion date

2019-11-01

Last updated

2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Under 18 Years Old With Kidney Disease

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.

Interventions

DRUGFFI-1010

Intravenous single dosing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ratio of Cin to Ccr measuring at the same time	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026