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Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Venofer and stable erythropoietin (EPO) regimen
stable erythropoietin (EPO) regimen
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring iron, peritoneal dialysis, anemia

Eligibility Criteria

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

Inclusion Criteria: Hemoglobin >= 9.5 and <= 11.5 g/dL. Ferritin <= 500 ng/ml. Serum Transferrin Saturation (TSAT) <= 25%. Stable erythropoietin (EPO) Regimen for 8 weeks. No iron for last 4 weeks before randomization. Exclusion Criteria: Known Sensitivity to Iron Sucrose. Suffering concomitant severe diseases of the liver & cardiovascular system. Pregnancy / Lactation. Inadequate dialysis. Current treatment for asthma. Significant blood loss. Probability of need for transfusion or transfusion within 1 week of enrollment. Anticipated major surgery. Hemochromatosis / hemosiderosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.

    Stable erythropoietin (EPO) dose and no supplemental iron.

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline to the Highest Hemoglobin up to Day 71

    Secondary Outcome Measures

    The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
    The Mean Change From Baseline to the Highest Ferritin up to Day 71
    The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71

    Full Information

    First Posted
    October 10, 2005
    Last Updated
    April 29, 2021
    Sponsor
    American Regent, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236938
    Brief Title
    Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
    Official Title
    Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    September 2004 (Actual)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    American Regent, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
    Detailed Description
    This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia
    Keywords
    iron, peritoneal dialysis, anemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    121 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Stable erythropoietin (EPO) dose and no supplemental iron.
    Intervention Type
    Drug
    Intervention Name(s)
    Venofer and stable erythropoietin (EPO) regimen
    Other Intervention Name(s)
    Iron Sucrose
    Intervention Description
    Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
    Intervention Type
    Drug
    Intervention Name(s)
    stable erythropoietin (EPO) regimen
    Other Intervention Name(s)
    EPO
    Intervention Description
    Stable erythropoietin (EPO) dose and no supplemental iron.
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline to the Highest Hemoglobin up to Day 71
    Time Frame
    Change from Baseline up to Day 71
    Secondary Outcome Measure Information:
    Title
    The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
    Time Frame
    Change from Baseline up to Day 71
    Title
    The Mean Change From Baseline to the Highest Ferritin up to Day 71
    Time Frame
    Change from Baseline up to Day 71
    Title
    The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
    Time Frame
    Change from Baseline up to Day 71

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hemoglobin >= 9.5 and <= 11.5 g/dL. Ferritin <= 500 ng/ml. Serum Transferrin Saturation (TSAT) <= 25%. Stable erythropoietin (EPO) Regimen for 8 weeks. No iron for last 4 weeks before randomization. Exclusion Criteria: Known Sensitivity to Iron Sucrose. Suffering concomitant severe diseases of the liver & cardiovascular system. Pregnancy / Lactation. Inadequate dialysis. Current treatment for asthma. Significant blood loss. Probability of need for transfusion or transfusion within 1 week of enrollment. Anticipated major surgery. Hemochromatosis / hemosiderosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark A Falone, MD
    Organizational Affiliation
    American Regent, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17699248
    Citation
    Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29.
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    Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

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