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Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 073 | Experimental | AMG 073 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. | Efficacy Assessment Phase - last 14 weeks of study |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase | Efficacy Assessment Phase - last 14 weeks of study | |
| To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| AMG 073 | Drug | 30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily |
|
| Efficacy Assessment Phase - last 14 weeks of study |
| To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase | Efficacy Assessment Phase - last 14 weeks of study |
| To evaluate the safety of AMG 073 compared with placebo. | Entire study - 26 weeks |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |