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Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

Primary Purpose

Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Aranesp®
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Disease focused on measuring Chronic Kidney Disease (CKD), Haemoglobin (Hb), Erthropoetin (EPO), End Stage Renal Disease (ESRD), Recombinant Human Erthropoetic (rHuEPO), Anaemia, Darbepoetin Alfa, Aranesp®, Haemodialysis, Clinical Trial

Eligibility Criteria

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

Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation [TSAT] greater than or equal to 20%) - Stable IV (epoetin alfa or beta) or SC rHuEPO (epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 180 mmHg on 2 separate occasions during screening) - Prior history (within 12 weeks before enrolment) of cardiovascular events including: acute myocardial ischemia; hospitalization for congestive heart failure; myocardial infarction. - Pregnant or breast-feeding women - Treatment with an investigational agent or device within 30 days before screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Known sensitivity to any of the products to be administered during dosing - Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
    Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)

    Secondary Outcome Measures

    Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
    Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
    Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
    Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period
    Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period
    Treatment period 1: Change in Hb between screening/baseline and the evaluation period
    Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period

    Full Information

    First Posted
    June 30, 2005
    Last Updated
    May 1, 2008
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00116701
    Brief Title
    Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
    Official Title
    A Study to Evaluate the Efficacy of Converting From Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects With Chronic Kidney Disease Receiving Haemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL. Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Disease
    Keywords
    Chronic Kidney Disease (CKD), Haemoglobin (Hb), Erthropoetin (EPO), End Stage Renal Disease (ESRD), Recombinant Human Erthropoetic (rHuEPO), Anaemia, Darbepoetin Alfa, Aranesp®, Haemodialysis, Clinical Trial

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Aranesp®
    Primary Outcome Measure Information:
    Title
    Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
    Title
    Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
    Secondary Outcome Measure Information:
    Title
    Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
    Title
    Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
    Title
    Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
    Title
    Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period
    Title
    Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period
    Title
    Treatment period 1: Change in Hb between screening/baseline and the evaluation period
    Title
    Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation [TSAT] greater than or equal to 20%) - Stable IV (epoetin alfa or beta) or SC rHuEPO (epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 180 mmHg on 2 separate occasions during screening) - Prior history (within 12 weeks before enrolment) of cardiovascular events including: acute myocardial ischemia; hospitalization for congestive heart failure; myocardial infarction. - Pregnant or breast-feeding women - Treatment with an investigational agent or device within 30 days before screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Known sensitivity to any of the products to be administered during dosing - Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
    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
    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_20040218.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

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