Study of FFI-1010 in Pediatric Kidney Disease

Fuji Yakuhin

Status and phase: Completed; Phase 3

Conditions: Children Under 18 Years Old With Kidney Disease

Treatments: Drug: FFI-1010

Study type: Interventional

Funder types: Industry

Identifiers

NCT03345316

FFI-1010-004

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

FFI-1010

Experimental group

Treatment:

Drug: FFI-1010