A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
- Registration Number
- NCT01850641
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PA21 PA21 -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events 12 weeks
- Secondary Outcome Measures
Name Time Method Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) 12 weeks Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) 12 weeks Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) 12 weeks Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) 12 weeks Constipation Condition 12 weeks Hb Concentrations at End of Treatment (Actual Measured Value) 12 weeks Satisfaction With Bowel Movement 12 weeks TSAT at End of Treatment (Actual Measured Value) 12 weeks