NCT01521494CompletedPhase 2
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Kissei Pharmaceutical Co., Ltd.1 site in 1 country183 target enrollmentStarted: January 11, 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Study Overview
Brief Summary
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
PA21 2250 mg/day
Experimental
Intervention: PA21 (Drug)
PA21 750 mg/day
Experimental
Intervention: PA21 (Drug)
PA21 1500 mg/day
Experimental
Intervention: PA21 (Drug)
PA21 3000 mg/day
Experimental
Intervention: PA21 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Time Frame: 6 weeks
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
Secondary Outcomes
- Change From Baseline in Serum Calcium Concentrations.(6 weeks)
- Change From Baseline in Serum Intact-PTH Concentrations.(6 weeks)
Investigators
Study Sites (1)
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