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

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. Identifier: NCT00110929
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : April 23, 2010
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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).

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: AMG 073 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2002

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Primary Outcome Measures :
  1. Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.

Secondary Outcome Measures :
  1. Examine safety and tolerability of cinacalcet.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110929

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00110929     History of Changes
Other Study ID Numbers: 20020158
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: April 2010

Keywords provided by Amgen:
Secondary HPT
End-Stage Renal Disease (ESRD)

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs