Hemodialysis Patients With Hyperphosphatemia Clinical Trial
Official title:
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
| Verified date | April 2015 |
| Source | Kissei Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.
| Status | Completed |
| Enrollment | 161 |
| Est. completion date | August 4, 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Receiving stable maintenance hemodialysis 3 times a week. - Dialysis patients with hyperphosphatemia Exclusion Criteria: - Patients having history of a pronounced brain / cardiovascular disorder. - Patients having severe gastrointestinal disorders. - Patients having severe hepatic disorders. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | JAPAN | Multiple Locations |
| Lead Sponsor | Collaborator |
|---|---|
| Kissei Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events | 52 weeks | ||
| Secondary | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 52 weeks | ||
| Secondary | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 52 weeks | ||
| Secondary | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 52 weeks |