Study Complete
Sponsor ID
20000172
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
Study Details
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.
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 treatment)
Secondary Outcome Measures
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
Timeframe: 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
Timeframe: efficacy assessment phase (last 14 weeks of treatment)
To evaluate the safety of AMG 073 compared with placebo.
Timeframe: entire study
Locations
No locations found.