NCT00527085CompletedPhase 2
A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 45
- Primary Endpoint
- To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AMG 073
Experimental
Intervention: AMG 073 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Time Frame: entire study
Secondary Outcomes
- 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)
Investigators
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