PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Phase 2
Completed
- Conditions
- Chronic Kidney Disease Requiring Hemodialysis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01521494
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Inclusion Criteria
- Patients age 20 or older, regardless of gender.
- Receiving stable maintenance hemodialysis 3 times a week.
- Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
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
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - PA21 1500 mg/day PA21 - PA21 3000 mg/day PA21 - PA21 2250 mg/day PA21 - PA21 750 mg/day PA21 -
- Primary Outcome Measures
Name Time Method Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. 6 weeks Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Serum Calcium Concentrations. 6 weeks Change From Baseline in Serum Intact-PTH Concentrations. 6 weeks
Trial Locations
- Locations (1)
Japan
🇯🇵Multiple Locations, Japan