Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis

Conditions
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Hyperparathyroidism

Intervention / Treatment
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* Drug: Placebo
* Drug: AMG 073


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women greater than or equal to 18 years of age Using effective contraceptive measures Mean iPTH during screening of greater than or equal to 300 pg/mL Mean calcium during screening of greater than or equal to 8.4 mg/dL Stable on hemodialysis Exclusion Criteria: Unstable medical conditions Parathyroidectomy within 3 months Change in Vitamin D therapy Receiving antidepressants Experienced an MI within 3 months Inability to swallow tablets Previously received AMG 073

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 073<br>AMG 073 | Drug: AMG 073<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |