Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01521494 | PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia | PHASE2 | COMPLETED | 183 | — | — | Jan 11, 2012 | Jul 3, 2012 | Aug 23, 2018 | 1 | Japan |
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
| Arm | Type | Description |
|---|---|---|
| PA21 750 mg/day | EXPERIMENTAL | - |
| PA21 1500 mg/day | EXPERIMENTAL | - |
| PA21 2250 mg/day | EXPERIMENTAL | - |
| PA21 3000 mg/day | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PA21 | DRUG | - |
| Placebo | DRUG | - |
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 histo...