12-month Study of AMG 073 in Renal Osteodystrophy
- Registration Number
- NCT00527085
- Lead Sponsor
- Amgen
- Brief Summary
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- 18 years of age of greater
- Using effective contraceptive measures
- iPTH greater than or equal to 300 pg/mL
- Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
- Stable hemodialysis for 1 month prior to day 1
Exclusion Criteria
- Any unstable medical condition
- Pregnant or nursing women Recent parathyroidectomy
- Change in Vitamin D therapy
- Recent MI, Seizure, Malignancy, GI Disorder
- Inability to swallow tablets
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 effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry entire study
- Secondary Outcome Measures
Name Time Method To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations entire study To evaluate the feasibility of measuring physical activity with accelerometry entire study To evaluate the safety and tolerability of AMG 073 compared with placebo entire study