Phase 3
N=161
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Hemodialysis Patients With Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT01833494 ↗Enrolled (actual)
161
Serious AEs
18.0%
Results posted
Oct 2018
Primary outcome: Primary: Incidence of Adverse Events — 152 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PA21 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
152 | — |
| SECONDARY Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) |
5.00 | — |
| SECONDARY Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) |
9.05 | — |
| SECONDARY Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |
251.6 | — |
Summary
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01833494). 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.