Children Under 18 Years Old With Kidney Disease Clinical Trial
Official title:
Safety and Usability Evaluation Study of FFI-1010 Single Administration for Children Under 18 Years Old With Kidney Disease (Phase III Study).
| Verified date | December 2019 |
| Source | Fuji Yakuhin Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 1, 2019 |
| Est. primary completion date | November 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Fuji Yakuhin Investigational sites | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Fuji Yakuhin Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |