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Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis

Primary Purpose

Chronic Kidney Disease, Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
De Novo Administration of 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 Anemia

Eligibility Criteria

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

Inclusion Criteria: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified MDRD (Modification of Diet in Renal Disease) equation: eGFR = 186 x [serum creatinine]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.212 if subject is black] - Clinically stable, in the judgment of the investigator - Mean Hb greater than or equal to 11.0 g/dL to less than or equal to 13.0 g/dL (mean of 2 values drawn at least 3 days apart during the screening period) - Transferrin saturation (Tsat) greater than or equal to 15.0% - Serum vitamin B12 and folate levels above the lower limit of the normal range - Receiving stable Q2W subcutaneous (SC) doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to a 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period Exclusion Criteria: - Prior recipient or scheduled to receive a kidney transplant - Diastolic blood pressure (BP) greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening - Acute myocardial ischemia - Hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment - Parathyroid hormone level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    darbepoetin alfa

    Arm Description

    Outcomes

    Primary Outcome Measures

    The proportion of subjects achieving a Hb ≥ 11.0 g/dL

    Secondary Outcome Measures

    Hb values over the duration of the study
    Darbepoetin alfa doses over the duration of the study
    Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure

    Full Information

    First Posted
    May 27, 2005
    Last Updated
    July 9, 2009
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00112008
    Brief Title
    Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis
    Official Title
    A Multi-Center, Single-Arm Study Evaluating De Novo Once Every Two Week Darbepoetin Alfa Dosing in Subjects With Chronic Kidney Disease (CKD) Not Receiving Dialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    darbepoetin alfa
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    De Novo Administration of Darbepoetin Alfa
    Intervention Description
    Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL
    Primary Outcome Measure Information:
    Title
    The proportion of subjects achieving a Hb ≥ 11.0 g/dL
    Time Frame
    Entire Study
    Secondary Outcome Measure Information:
    Title
    Hb values over the duration of the study
    Time Frame
    Entire Study
    Title
    Darbepoetin alfa doses over the duration of the study
    Time Frame
    Entire Study
    Title
    Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure
    Time Frame
    Entire Study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified MDRD (Modification of Diet in Renal Disease) equation: eGFR = 186 x [serum creatinine]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.212 if subject is black] - Clinically stable, in the judgment of the investigator - Mean Hb greater than or equal to 11.0 g/dL to less than or equal to 13.0 g/dL (mean of 2 values drawn at least 3 days apart during the screening period) - Transferrin saturation (Tsat) greater than or equal to 15.0% - Serum vitamin B12 and folate levels above the lower limit of the normal range - Receiving stable Q2W subcutaneous (SC) doses of Aranesp® (darbepoetin alfa). A stable dose is defined as less than or equal to a 25% change in dose over the 6-week period immediately prior to enrollment and with no missed doses in this period Exclusion Criteria: - Prior recipient or scheduled to receive a kidney transplant - Diastolic blood pressure (BP) greater than 110 mm Hg or systolic BP greater than 180 mm Hg during screening - Acute myocardial ischemia - Hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment - Parathyroid hormone level greater than 1500 pg/mL - Major surgery within 12 weeks before enrollment (excluding vascular access surgery) - Currently receiving antibiotic therapy for systemic infection - Known positive HIV antibody or positive hepatitis B surface antigen - Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia - Red blood cell (RBC) transfusions within 8 weeks before enrollment - Androgen therapy within 8 weeks before enrollment - Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) - Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study - Pregnant or breast-feeding women - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial - Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study
    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
    19210145
    Citation
    Silver MR, Geronemus R, Krause M, Chen CY, Kewalramani R, Stehman-Breen C. Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis-stimulating agents. Curr Med Res Opin. 2009 Jan;25(1):123-31. doi: 10.1185/03007990802594818.
    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/20030237.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 for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis

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