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Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Primary Purpose

Secondary Hyperparathyroidism, Chronic Renal Insufficiency

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cinacalcet (AMG 073)
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

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

Inclusion Criteria: Patients must have chronic renal insufficiency (pre-dialysis) Have below normal creatinine clearance Have elevated parathyroid hormone levels Exclusion Criteria: Pregnant or nursing Heart attack in the last 3 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    cinacalcet (AMG 073)

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
    Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase

    Secondary Outcome Measures

    Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
    Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase

    Full Information

    First Posted
    July 29, 2002
    Last Updated
    May 9, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00042432
    Brief Title
    Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
    Official Title
    A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    August 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Secondary Hyperparathyroidism, Chronic Renal Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cinacalcet (AMG 073)
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    cinacalcet (AMG 073)
    Intervention Description
    Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
    Primary Outcome Measure Information:
    Title
    Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
    Description
    Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
    Time Frame
    Efficacy assessment phase (weeks 12-18)
    Secondary Outcome Measure Information:
    Title
    Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
    Description
    Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
    Time Frame
    Baseline, efficacy assessment phase (weeks 12-18)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have chronic renal insufficiency (pre-dialysis) Have below normal creatinine clearance Have elevated parathyroid hormone levels Exclusion Criteria: Pregnant or nursing Heart attack in the last 3 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15983958
    Citation
    Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. doi: 10.1053/j.ajkd.2005.04.013.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://www.sensipar.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

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