A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
Phase 3
Completed
- Conditions
- Secondary HyperparathyroidismEnd Stage Renal Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT00037635
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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 - 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 treatment)
- Secondary Outcome Measures
Name Time Method 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 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 efficacy assessment phase (last 14 weeks of treatment) To evaluate the safety of AMG 073 compared with placebo. entire study