Back to resultsTreatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 073
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Sensipar®, Secondary HPT, Mimpara®, Cinacalcet, calcimimetic, End-Stage Renal Disease (ESRD)
Eligibility Criteria
Inclusion Criteria: - Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study Exclusion Criteria: - Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
Sites / Locations
Outcomes
Primary Outcome Measures
Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.
Secondary Outcome Measures
Examine safety and tolerability of cinacalcet.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00110929
Brief Title
Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
Official Title
A Study to Compare the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) When Two Different Vitamin D Regimens Are Used in Subjects With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Sensipar®, Secondary HPT, Mimpara®, Cinacalcet, calcimimetic, End-Stage Renal Disease (ESRD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
850 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AMG 073
Primary Outcome Measure Information:
Title
Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.
Secondary Outcome Measure Information:
Title
Examine safety and tolerability of cinacalcet.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study Exclusion Criteria: - Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
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
19696213
Citation
Sprague SM, Evenepoel P, Curzi MP, Gonzalez MT, Husserl FE, Kopyt N, Sterling LR, Mix C, Wong G. Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl. Clin J Am Soc Nephrol. 2009 Sep;4(9):1465-76. doi: 10.2215/CJN.06141108. Epub 2009 Aug 20.
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_20020158.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
URL
http://download.veritasmedicine.com/REGFILES/amgen/20020158.pdf
Description
To access clinical trial results information click on this link
Learn more about this trial
Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
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