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The primary objectives of this study are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 223 | Drug | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the AMG 223 will produce a statistically significant reduction in serum phosphorus compared with placebo over a 3 week treatment period in subjects with CKD receiving dialysis | TREATMENT PERIOD |
| Measure | Description | Time Frame |
|---|---|---|
| To describe a dose response for AMG 223 | TREATMENT PERIOD | |
| To evaluate the safety and tolerability of AMG 223 | ENTIRE STUDY |
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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 |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo |
| Drug |
1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |