Study Complete
Sponsor ID
20000183
Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects
Study Details
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.
Protocol Summary
Primary Outcome Measures
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.
Timeframe: Efficacy Assessment Phase - last 14 weeks of study
Secondary Outcome Measures
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
Timeframe: 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
Timeframe: 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
Timeframe: Efficacy Assessment Phase - last 14 weeks of study
To evaluate the safety of AMG 073 compared with placebo.
Timeframe: Entire study - 26 weeks
Locations
No locations found.