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Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

Primary Purpose

Kidney Disease, Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
darbepoetin alfa SF
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis Anemic Currently on erythropoietic therapy Controlled hypertension Clinically stable

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    darbepoetin alfa SF

    Arm Description

    Outcomes

    Primary Outcome Measures

    To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile

    Secondary Outcome Measures

    To characterize laboratory parameters in subjects with CKD

    Full Information

    First Posted
    October 7, 2004
    Last Updated
    May 22, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00093977
    Brief Title
    Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
    Official Title
    An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    darbepoetin alfa SF
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    darbepoetin alfa SF
    Intervention Description
    Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL
    Primary Outcome Measure Information:
    Title
    To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
    Time Frame
    Entire Study
    Secondary Outcome Measure Information:
    Title
    To characterize laboratory parameters in subjects with CKD
    Time Frame
    Entire Study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis Anemic Currently on erythropoietic therapy Controlled hypertension Clinically stable
    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
    19954265
    Citation
    Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    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_33_NESP_20040180.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com
    Description
    FDA-approved Drug Labeling

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    Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

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