Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

Last updated: November 3, 2022
Sponsor: Amgen
Overall Status: Terminated

Phase

3

Condition

Nephropathy

Anemia

Renal Failure

Treatment

N/A

Clinical Study ID

NCT00436748
20050256
  • Ages 1-18
  • All Genders

Study Summary

The primary objectives of this study are the following:

  1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and

  2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current diagnosis of Chronic Kidney Disease, either receiving or not receivingdialysis
  • Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart < 11.0 g/dL
  • Transferrin saturation (Tsat) greater than or equal to 20%

Exclusion

Exclusion Criteria:

  • Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization
  • other hematologic disorders
  • upper or lower gastrointenstinal bleeding within 6 months prior to randomization
  • uncontrolled hypertension
  • prior history (within 12 weeks prior to randomization) of acute myocardial ischemia,hospitalization for congestive heart failure, myocardial infarction, stroke ortransient ischemic attack
  • prior history (within 6 months prior to randomization) of thromboembolism

Study Design

Total Participants: 116
Study Start date:
September 16, 2008
Estimated Completion Date:
March 03, 2014

Connect with a study center

  • Research Site

    Edegem, 2650
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Research Site

    Jurmala, 2015
    Latvia

    Site Not Available

  • Research Site

    Vilnius, 08406
    Lithuania

    Site Not Available

  • Research Site

    Mexico, Distrito Federal 06720
    Mexico

    Site Not Available

  • Research Site

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • Research Site

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Research Site

    Puebla, 72190
    Mexico

    Site Not Available

  • Research Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • Research Site

    Lodz, 93-338
    Poland

    Site Not Available

  • Research Site

    Szczecin, 70-410
    Poland

    Site Not Available

  • Research Site

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Research Site

    Krasnodar, 350033
    Russian Federation

    Site Not Available

  • Research Site

    Moscow, 117997
    Russian Federation

    Site Not Available

  • Research Site

    Orenburg, 460004
    Russian Federation

    Site Not Available

  • Research Site

    Saint Petersburg, 198205
    Russian Federation

    Site Not Available

  • Research Site

    Samara, 443095
    Russian Federation

    Site Not Available

  • Research Site

    Banska Bystrica, 974 09
    Slovakia

    Site Not Available

  • Research Site

    Bratislava, 833 40
    Slovakia

    Site Not Available

  • Research Site

    Kosice, 040 11
    Slovakia

    Site Not Available

  • Research Site

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Research Site

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Research Site

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Research Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    San Diego, California 92123
    United States

    Site Not Available

  • Research Site

    San Francisco, California 94143
    United States

    Site Not Available

  • Research Site

    Stanford, California 94305-5208
    United States

    Site Not Available

  • Research Site

    Wahington, District of Columbia
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia 20010
    United States

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  • Research Site

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Research Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Research Site

    Boise, Idaho 83712
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Research Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Research Site

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Research Site

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Research Site

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Research Site

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10467
    United States

    Site Not Available

  • Research Site

    Buffalo, New York 14222
    United States

    Site Not Available

  • Research Site

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Research Site

    New York, New York 10029
    United States

    Site Not Available

  • Research Site

    Valhalla, New York 10595
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Research Site

    Akron, Ohio 44308
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Research Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98105
    United States

    Site Not Available

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