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Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

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ClinicalTrials.gov Identifier: NCT00527267
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 26, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism Drug: Placebo Drug: AMG 073 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis
Study Start Date : February 2002
Primary Completion Date : April 2003
Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AMG 073
AMG 073
Drug: AMG 073
30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo
30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase. [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ]
  2. To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ]
  3. To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase [ Time Frame: Efficacy Assessment Phase - last 14 weeks of study ]
  4. To evaluate the safety of AMG 073 compared with placebo. [ Time Frame: Entire study - 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men and Women greater than or equal to 18 years of age
  • Using effective contraceptive measures
  • Mean iPTH during screening of greater than or equal to 300 pg/mL
  • Mean calcium during screening of greater than or equal to 8.4 mg/dL
  • Stable on hemodialysis

Exclusion Criteria:

  • Unstable medical conditions
  • Parathyroidectomy within 3 months
  • Change in Vitamin D therapy
  • Receiving antidepressants
  • Experienced an MI within 3 months
  • Inability to swallow tablets
  • Previously received AMG 073
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00527267


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

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00527267     History of Changes
Other Study ID Numbers: 20000183
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs