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This 6 month 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 | AMG 073 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken 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 - final 10 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 mean iPTH of >= 30% during the efficacy assessment phase | Efficacy Assessment phase - final 10 weeks of study | |
| To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase |
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Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15689407 | Result | Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2. |
| 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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| AMG 073 | Drug | 30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally |
|
| Efficacy Assessment phase - final 10 weeks of study |
| To evaluate the safety of AMG 073 compared with placebo | Entire study - 26 weeks |
| To access clinical trial results information click on this link | View source |
| FDA-approved Drug Labeling | View source |
| 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 |