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Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00110929
First Posted: May 17, 2005
Last Update Posted: April 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
May 16, 2005
May 17, 2005
April 23, 2010
November 2002
Not Provided
Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.
Not Provided
Complete list of historical versions of study NCT00110929 on ClinicalTrials.gov Archive Site
Examine safety and tolerability of cinacalcet.
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Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
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)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
Drug: AMG 073
Not Provided
Sprague SM, Evenepoel P, Curzi MP, González 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
850
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Canada,   France,   United Kingdom,   United States
 
NCT00110929
20020158
Not Provided
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Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP