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Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Iron Sucrose + Erythropoietin
Ferrous Sulfate + Erythropoietin
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Anemia focused on measuring Anemia, Chronic Kidney Disease

Eligibility Criteria

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

Inclusion Criteria: Creatine Clearance <40 mL/min Average Baseline Hemoglobin < 10.5g/dL TSAT < 25% and Ferritin <300ng/mL Exclusion Criteria: Blood Transfusion within 30days Uncontrolled Hypertension Suffering form concommitant disease of the liver Serious bacterial infection Pregnancy / lactation Symptomatic HIV Expected to under dialysis or renal transplant during study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mean Change in Hemoglobin and Serum Ferritin at day 43

    Secondary Outcome Measures

    Clinical success (change in Hgb > 12 & Change in Ferritin 180)
    Maximum change in Hemoglobin during the study

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    January 22, 2018
    Sponsor
    American Regent, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236964
    Brief Title
    Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
    Official Title
    Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    American Regent, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
    Detailed Description
    Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    78 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Iron Sucrose + Erythropoietin
    Intervention Type
    Drug
    Intervention Name(s)
    Ferrous Sulfate + Erythropoietin
    Primary Outcome Measure Information:
    Title
    Mean Change in Hemoglobin and Serum Ferritin at day 43
    Secondary Outcome Measure Information:
    Title
    Clinical success (change in Hgb > 12 & Change in Ferritin 180)
    Title
    Maximum change in Hemoglobin during the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Creatine Clearance <40 mL/min Average Baseline Hemoglobin < 10.5g/dL TSAT < 25% and Ferritin <300ng/mL Exclusion Criteria: Blood Transfusion within 30days Uncontrolled Hypertension Suffering form concommitant disease of the liver Serious bacterial infection Pregnancy / lactation Symptomatic HIV Expected to under dialysis or renal transplant during study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Falone, MD
    Organizational Affiliation
    Medical Director
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15824508
    Citation
    Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
    Results Reference
    result

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    Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

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