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This 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 073 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 073 | Drug | 30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD 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 treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase | efficacy assessment phase (last 14 weeks of treatment) | |
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16105056 | Result | Martin KJ, Juppner H, Sherrard DJ, Goodman WG, Kaplan MR, Nassar G, Campbell P, Curzi M, Charytan C, McCary LC, Guo MD, Turner SA, Bushinsky DA. First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl. Kidney Int. 2005 Sep;68(3):1236-43. doi: 10.1111/j.1523-1755.2005.00517.x. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051436 | Renal Insufficiency, Chronic |
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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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| Placebo |
| Drug |
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally |
|
| efficacy assessment phase (last 14 weeks of treatment) |
| To evaluate the safety of AMG 073 compared with placebo. | entire study |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |