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Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Primary Purpose

Hyperparathyroidism

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
AMG 073
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    AMG 073

    Placebo

    Arm Description

    AMG 073

    Placebo

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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
    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
    To evaluate the safety of AMG 073 compared with placebo.

    Full Information

    First Posted
    September 6, 2007
    Last Updated
    January 22, 2009
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00527267
    Brief Title
    Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    April 2003 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperparathyroidism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    320 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AMG 073
    Arm Type
    Experimental
    Arm Description
    AMG 073
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 073
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    To evaluate the safety of AMG 073 compared with placebo.
    Time Frame
    Entire study - 26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    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_20000183.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

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    Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

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