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Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Darbepoetin Alfa
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Dialysis, Anaemia

Eligibility Criteria

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

Inclusion Criteria:

  • Receiving dialysis for 3 months or more before enrollment.
  • The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
  • Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
  • Adequate iron stores (serum ferritin equal to or greater than 100 ug/L

Exclusion Criteria:

  • Uncontrolled hypertension
  • Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
  • Other hematological disorders
  • Upper or lower GI bleed within the prior 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single

    Arm Description

    Outcomes

    Primary Outcome Measures

    Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.

    Secondary Outcome Measures

    Q2W doses over duration of study.
    Hb values during the evaluation period.
    adverse events during study
    Hb Rate of Rise during study and excursions above 14g/dL

    Full Information

    First Posted
    February 15, 2007
    Last Updated
    January 20, 2011
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00436995
    Brief Title
    Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
    Official Title
    A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease
    Keywords
    Dialysis, Anaemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin Alfa
    Intervention Description
    Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
    Primary Outcome Measure Information:
    Title
    Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
    Time Frame
    33 weeks
    Secondary Outcome Measure Information:
    Title
    Q2W doses over duration of study.
    Time Frame
    33 weeks
    Title
    Hb values during the evaluation period.
    Time Frame
    33 weeks
    Title
    adverse events during study
    Time Frame
    33 weeks
    Title
    Hb Rate of Rise during study and excursions above 14g/dL
    Time Frame
    33 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Receiving dialysis for 3 months or more before enrollment. The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment Adequate iron stores (serum ferritin equal to or greater than 100 ug/L Exclusion Criteria: Uncontrolled hypertension Prior history of Cardiovascular Incidents 12 weeks prior to enrollment Other hematological disorders Upper or lower GI bleed within the prior 6 months
    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://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

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