Back to results12-month Study of AMG 073 in Renal Osteodystrophy
Primary Purpose
Renal Osteodystrophy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 073
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Osteodystrophy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 073
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00527085
Brief Title
12-month Study of AMG 073 in Renal Osteodystrophy
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 Hemodialysis Patients With Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Osteodystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMG 073
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AMG 073
Intervention Description
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
Primary Outcome Measure Information:
Title
To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
Time Frame
entire study
Secondary Outcome Measure Information:
Title
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
Title
To evaluate the feasibility of measuring physical activity with accelerometry
Time Frame
entire study
Title
To evaluate the safety and tolerability of AMG 073 compared with placebo
Time Frame
entire study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18397701
Citation
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.
Results Reference
result
Links:
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_38_AMG_073_20010141.pdf
Description
To access clinical trial results information click on this link
URL
http://www.sensipar.com/
Description
FDA-approved Drug Labeling
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
12-month Study of AMG 073 in Renal Osteodystrophy
We'll reach out to this number within 24 hrs