Phase 3
N=35
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Hemodialysis · Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT01850641 ↗Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Oct 2018
Primary outcome: Primary: Incidence of Adverse Events — 28 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
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
28 | — |
| SECONDARY Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) |
4.89 | — |
| SECONDARY Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) |
9.52 | — |
| SECONDARY Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |
177.9 | — |
| SECONDARY Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) |
73.8 | — |
| SECONDARY TSAT at End of Treatment (Actual Measured Value) |
27.72 | — |
| SECONDARY Hb Concentrations at End of Treatment (Actual Measured Value) |
11.22 | — |
| SECONDARY Constipation Condition |
15; 14; 2; 4; 0; 26 | — |
| SECONDARY Satisfaction With Bowel Movement |
21; 8; 6; 28; 5; 2 | — |
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.
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 (NCT01850641). 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.