Clinical Trial: 12-month Study of AMG 073 in Renal Osteodystrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Hemodi
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 Summary:
Sponsor: Amgen
Current Primary Outcome: To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry [ Time Frame: entire study ]
Original Primary Outcome: To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Current Secondary Outcome:
- 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 [ Time Frame: entire study ]
- To evaluate the feasibility of measuring physical activity with accelerometry [ Time Frame: entire study ]
- To evaluate the safety and tolerability of AMG 073 compared with placebo [ Time Frame: entire study ]
Original Secondary Outcome:
- 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
- To evaluate the feasibility of measuring physical activity with accelerometry
- To evaluate the safety and tolerability of AMG 073 compared with placebo
Information By: Amgen
Dates:
Date Received: September 6, 2007
Date Started: October 2001
Date Completion:
Last Updated: May 6, 2013
Last Verified: May 2013
