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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00530114 | Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia | PHASE2 | COMPLETED | 167 | — | — | Mar 1, 2008 | Feb 1, 2009 | Mar 14, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| AMG 223 | EXPERIMENTAL | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| Name | Type | Description |
|---|---|---|
| AMG 223 | DRUG | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| Placebo | DRUG | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
Inclusion Criteria: * Maintenance hemodialysis 3 times a week for at least 3 months prior to screening * Single pool Kt/V at least 1.2 or urea reduction ratio at least 65% * Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening * No change(s) in type or dose of non-investigational phosp...