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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00704678 | Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis | PHASE2 | COMPLETED | 203 | — | — | Aug 1, 2008 | - | Sep 23, 2016 | 15 | Japan, Taiwan |
| NCT00750295 | A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis | PHASE1 | COMPLETED | 60 | — | — | Feb 1, 2007 | Jan 1, 2008 | Dec 19, 2020 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 1g bid |
| 2 | ACTIVE_COMPARATOR | 0.8 g tid |
| 3 | EXPERIMENTAL | 1.5 g tid |
| 4 | ACTIVE_COMPARATOR | 1.6 g tid |
| 5 | EXPERIMENTAL | - |
| 6 | EXPERIMENTAL | - |
| 7 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SBR759 | DRUG | 1g tid |
| Sevelamer HCl | DRUG | 1.6 g tid |
Inclusion criteria * Men or women of at least 18 years old or 20 years old in Japan. * Stable maintenance of hemodialysis 3 times per week. * Controlled serum phosphate if under phosphate-binder therapy. * Serum phosphate level \> 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation. Excl...