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STAAR-2 Clinical Study

Primary Purpose

Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease

Status
Completed
Phase
Phase 4
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 Aranesp, Anemia, Kidney Disease, Hemoglobin, darbepoetin alfa, QoL

Eligibility Criteria

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

Inclusion Criteria: ≥ 18 years old diagnosis of CRI and not receiving dialysis therapy (must be predialysis) measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula): Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0 For women, the value will be multiplied by 0.85 MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [sun] -0.170SAlb]-0.318 mean Hgb < 11 g/dL during the screening/baseline period (if subject is not already receiving rHuEPO therapy) for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly. white blood cell and platelet counts within normal limits serum vitamin B12 and folate levels above the lower limit of normal range transferrin saturation (TSAT) ≥ 20% during the screening period availability for follow-up assessments subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study Exclusion Criteria: scheduled to initiate dialysis uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements) clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc) scheduled to receive a living donor kidney transplant treatment of grand mal epilepsy within the past 6 months moderate to severe congestive heart failure (NYHA class III or IV) clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level > 1500 pg/mL) severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc) currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended) known aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening known positive HIV antibody or hepatitis B surface antigen clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia active bleeding or RBC transfusion within eight weeks of enrollment androgen therapy within four weeks before enrollment known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc) any condition that is likely to affect subject compliance currently or previously (within 30 days) enrolled in investigational device or drug trial(s) or receiving investigational agent(s) the exception to this is if the subject was enrolled in another Aranesp™ or rHuEPO protocol pregnant or breast feeding women (women of child-bearing potential must be using contraceptive precautions) women planning to have a child during the study period known hypersensitivity to the active substance or any of the excipients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single arm

    Arm Description

    Every other week dosing of Aranesp SC

    Outcomes

    Primary Outcome Measures

    Mean hemoglobin during the evaluation period

    Secondary Outcome Measures

    Change in hemoglobin throughout the study
    HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study
    Health-related resource utilization, measured every 4 weeks, throughout the study
    Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12
    Iron requirement (dose, frequency, and route) of subjects during the study

    Full Information

    First Posted
    August 24, 2006
    Last Updated
    March 4, 2010
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00368901
    Brief Title
    STAAR-2 Clinical Study
    Official Title
    A Multicenter Study Using Once Every Other Week Subcutaneous Administration of Aranesp™ (Darbepoetin Alfa) and Iron Guided Algorithms to Treat Subjects With Anemia of Chronic Renal Insufficiency (CRI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    March 2004 (Actual)
    Study Completion Date
    May 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.
    Detailed Description
    To assess the effect of Aranesp_ on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. To assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment. To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp_ compared to previous rHuEPO therapy. To characterize iron treatment in subjects with CRI. To assess the safety profile of Aranesp_ therapy in subjects with CRI

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, Chronic Renal Insufficiency, Kidney Disease, Pre-dialysis, Pre-ESRD
    Keywords
    Aranesp, Anemia, Kidney Disease, Hemoglobin, darbepoetin alfa, QoL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    618 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Experimental
    Arm Description
    Every other week dosing of Aranesp SC
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa
    Other Intervention Name(s)
    Aranesp
    Intervention Description
    Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL
    Primary Outcome Measure Information:
    Title
    Mean hemoglobin during the evaluation period
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    Change in hemoglobin throughout the study
    Time Frame
    52 weeks
    Title
    HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study
    Time Frame
    52 weeks
    Title
    Health-related resource utilization, measured every 4 weeks, throughout the study
    Time Frame
    52 weeks
    Title
    Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12
    Time Frame
    12 weeks
    Title
    Iron requirement (dose, frequency, and route) of subjects during the study
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥ 18 years old diagnosis of CRI and not receiving dialysis therapy (must be predialysis) measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula): Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0 For women, the value will be multiplied by 0.85 MDRD formula: GFR = 170 x [SCr]-0.999 x [Age]-0.167 x [0.762 if subject is female] x [1.180 if subject is black] x [sun] -0.170SAlb]-0.318 mean Hgb < 11 g/dL during the screening/baseline period (if subject is not already receiving rHuEPO therapy) for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly. white blood cell and platelet counts within normal limits serum vitamin B12 and folate levels above the lower limit of normal range transferrin saturation (TSAT) ≥ 20% during the screening period availability for follow-up assessments subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study Exclusion Criteria: scheduled to initiate dialysis uncontrolled hypertension (diastolic blood pressure > 105 mm Hg or systolic blood pressure of > 180 mm Hg during the screening/baseline period on two separate measurements) clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc) scheduled to receive a living donor kidney transplant treatment of grand mal epilepsy within the past 6 months moderate to severe congestive heart failure (NYHA class III or IV) clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level > 1500 pg/mL) severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc) currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended) known aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening known positive HIV antibody or hepatitis B surface antigen clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia active bleeding or RBC transfusion within eight weeks of enrollment androgen therapy within four weeks before enrollment known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc) any condition that is likely to affect subject compliance currently or previously (within 30 days) enrolled in investigational device or drug trial(s) or receiving investigational agent(s) the exception to this is if the subject was enrolled in another Aranesp™ or rHuEPO protocol pregnant or breast feeding women (women of child-bearing potential must be using contraceptive precautions) women planning to have a child during the study period known hypersensitivity to the active substance or any of the excipients
    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
    18328118
    Citation
    Abu-Alfa AK, Sloan L, Charytan C, Sekkarie M, Scarlata D, Globe D, Audhya P. The association of darbepoetin alfa with hemoglobin and health-related quality of life in patients with chronic kidney disease not receiving dialysis. Curr Med Res Opin. 2008 Apr;24(4):1091-100. doi: 10.1185/030079908x280653. Epub 2008 Mar 6.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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    STAAR-2 Clinical Study

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