A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis
Phase 3
Completed
- Conditions
- Secondary HyperparathyroidismEnd Stage Renal Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT00042653
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
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 - final 10 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 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 Efficacy Assessment phase - final 10 weeks of study To evaluate the safety of AMG 073 compared with placebo Entire study - 26 weeks