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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110929
First received: May 16, 2005
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
End Stage Renal Disease
Drug: AMG 073
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Amgen:

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.

Estimated Enrollment: 850
Study Start Date: November 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00110929

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00110929     History of Changes
Other Study ID Numbers: 20020158
Study First Received: May 16, 2005
Last Updated: April 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Sensipar®
Secondary HPT
Mimpara®
Cinacalcet
calcimimetic
End-Stage Renal Disease (ESRD)

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014