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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01464190 | A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients | PHASE3 | COMPLETED | 659 | — | — | Sep 1, 2011 | Apr 1, 2013 | Apr 1, 2014 | 15 | United States, Austria +13 |
| NCT01324128 | A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients | PHASE3 | COMPLETED | 1,059 | — | — | Mar 1, 2011 | Oct 1, 2012 | Apr 24, 2014 | 15 | United States, Austria +13 |
| NCT03644264 | PA21 Safety and Efficacy in Adult Chinese Subjects | PHASE3 | COMPLETED | 286 | — | — | Aug 31, 2018 | Aug 21, 2020 | Jun 2, 2021 | 1 | China |
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
Change from baseline in serum phosphorus levels at Week 12: comparison between PA21 group and sevelamer carbonate group.
| Arm | Type | Description |
|---|---|---|
| PA21 | EXPERIMENTAL | - |
| Sevelamer carbonate | ACTIVE_COMPARATOR | - |
| PA21 (2.5 g tablet) | EXPERIMENTAL | - |
| PA21-1 (1.25 g tablet) | OTHER | - |
| PA21 tablets containing 500 mg of iron | EXPERIMENTAL | PA21 chewable tablets standardised to contain 500 mg of iron. PA21 500 mg (iron) chewable tablet contains approximately 2.5 g PA21 drug substance (sucroferric oxyhydroxide). Starting dose will be 1,500 mg/day (3 tablets/day (1 tablet per meal)). Dose increases or decreases of 500 mg/day (1 tablet/day) are permitted. The maximum dose of PA21 will be 3,000 mg/day (6 x 500 mg tablets/day) and the minimum dose will be 1,000 mg/day (2 x 500 mg tablets/day). |
| Sevelamer carbonate: Renvela® tablets | ACTIVE_COMPARATOR | Starting dose will be 2.4 g/day (3 tablets/day). Dose increases or decreases of 2.4 g/day (3 tablets/day (1 tablet per meal)) The maximum dose of sevelamer carbonate will be 14.4 g/day (18 tablets/day) and the minimum dose will be 2.4 g/day (3 tablets/day). |
| Name | Type | Description |
|---|---|---|
| PA21 (2.5 g tablet containing 500 mg iron) | DRUG | Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). |
| Sevelamer carbonate | DRUG | Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day). |
| PA21-1 (1.25 g tablet containing 250 mg iron) | DRUG | Low dose comparator (1.25 g/day) |
| PA21 | DRUG | sucroferric oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide (about 33% m/m), sucrose (about 30% m/m), and starches (about 28% m/m) and contains ≤10% m/m water. |
Inclusion Criteria: * Subjects who have completed treatment in Protocol PA-CL-05A * Written Informed Consent Exclusion Criteria: * Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH) * Other significant medical conditions * Pregnancy