12-month Study of AMG 073 in Renal Osteodystrophy
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
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedMay 8, 2013
May 1, 2013
1.8 years
September 6, 2007
May 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
entire study
Secondary Outcomes (3)
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
Study Arms (2)
AMG 073
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Malluche HH, Monier-Faugere MC, Wang G, Fraza O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. Clin Nephrol. 2008 Apr;69(4):269-78. doi: 10.5414/cnp69269.
PMID: 18397701RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
October 1, 2001
Primary Completion
August 1, 2003
Study Completion
August 1, 2003
Last Updated
May 8, 2013
Record last verified: 2013-05