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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03010072 | The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum | PHASE2 | COMPLETED | 40 | — | — | Jun 9, 2017 | May 10, 2019 | Jul 22, 2019 | 1 | Austria |
The primary outcome is change in the mean T50- Test values between different study phases (wash-out/treatment/control).
| Arm | Type | Description |
|---|---|---|
| low-dose sucroferric oxyhydroxide | ACTIVE_COMPARATOR | Low dose 250 mg sucroferric oxyhydroxide (PA21) per day (1x 250mg tablets/day) for 14 days. |
| high-dose sucroferric oxyhydroxide | ACTIVE_COMPARATOR | Uniform dose 2000 mg of sucroferric oxyhydroxide (PA21) per day (4x 500mg tablets/day) for 14 days |
| Name | Type | Description |
|---|---|---|
| low-dose sucroferric oxyhydroxide | DRUG | 250 mg suroferric oxyhydroxide |
| high-dose sucroferric oxyhydroxide | DRUG | 2000 mg suroferric oxyhydroxide |
Inclusion Criteria: * Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF) * Hyperphosphatemia (serum phosphate \> upper limit of normal within the last 3 months) or current phosphate binder use * No use or constant dose of vitamin D an...