Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 223 · 1 trial · 4 indications
| 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...
AMG 223 was studied for hyperphosphatemia in patients with chronic kidney disease who are on hemodialysis, a population that includes end stage renal disease. It is an investigational small molecule developed by Amgen. Its clinical program focused on lowering phosphate levels in dialysis-dependent kidney disease patients.
AMG 223 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen sponsored the clinical trial evaluating the drug in patients with chronic kidney disease on hemodialysis with hyperphosphatemia.
AMG 223 is in Phase 2 development. It is an investigational agent and has not been approved by the FDA. The Phase 2 study has been completed, and no active trials of AMG 223 are currently listed.
AMG 223 was evaluated in one Phase 2 trial, NCT00530114, titled a study to assess fixed dosing of AMG 223 in subjects with chronic kidney disease on hemodialysis with hyperphosphatemia. The trial enrolled 167 participants, was randomized, double blind, and placebo controlled, and it is now completed.
The Phase 2 trial NCT00530114 was a randomized, double blind, placebo controlled study of fixed dosing of AMG 223 in adults 18 years and older with chronic kidney disease on hemodialysis with hyperphosphatemia. It enrolled 167 participants and included both male and female patients. The study is completed.