Phase 2
N=183
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Chronic Kidney Disease Requiring Hemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT01521494 ↗Enrolled (actual)
183
Serious AEs
3.8%
Results posted
Aug 2018
Primary outcome: Primary: Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. — -1.84; -2.59; -3.17; -3.78 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PA21 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. |
-1.84; -2.59; -3.17; -3.78; 0.14 | — |
| SECONDARY Change From Baseline in Serum Calcium Concentrations. |
0.20; 0.16; 0.38; 0.38; -0.09 | — |
| SECONDARY Change From Baseline in Serum Intact-PTH Concentrations. |
-35.2; -45.6; -97.0; -86.5; 21.5 | — |
Summary
To investigate dose-response efficacy and safety 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 (NCT01521494). 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.