Phase 3
N=213
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Hemodialysis · Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT01850602 ↗Enrolled (actual)
213
Serious AEs
5.2%
Results posted
Oct 2018
Primary outcome: Primary: Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment — 5.00; 5.34 mg/dL — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PA21 (Drug); Sevelamer hydrochloride (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment |
5.00; 5.34 | 0.020 sig |
| SECONDARY Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) |
5.01; 5.33 | — |
| SECONDARY Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) |
9.14; 8.91 | — |
| SECONDARY Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |
203.6; 253.1 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01850602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.