Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Phase 3

Completed

• Conditions: Hyperparathyroidism
• Interventions: Drug: AMG 073; Drug: Placebo

• Registration Number: NCT00527267
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-06
• Study First Posted: 2007-09-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-22
• Last Update Posted: 2009-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 073	AMG 073	AMG 073
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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