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NESP Pediatric Study

Primary Purpose

Pre-dialysis, End Stage Renal Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
darbepoetin alfa
rHuEPO
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-dialysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • 1 to 18 years of age
  • ESRD receiving dialysis or CRI with eGFR less than 30 mL/min
  • Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete
  • Stable rHuEPO therapy for 8 weeks

Exclusion Criteria:

  • Scheduled for a living-related kidney transplant
  • Uncontrolled blood pressure
  • seizure activity
  • Hyperparathyroidism
  • Major surgery within 12 weeks or active inflammatory disease
  • Currently receiving antibiotics
  • Clinical evidence of malignancy
  • Pregnant or breast-feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    rHuEPO

    darbepoetin alfa

    Arm Description

    Outcomes

    Primary Outcome Measures

    To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis

    Secondary Outcome Measures

    To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD

    Full Information

    First Posted
    September 6, 2007
    Last Updated
    May 6, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00527137
    Brief Title
    NESP Pediatric Study
    Official Title
    An Open-label, Randomized, Non-inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (rHuEPO) for the Treatment of Anemia in Pediatric Subjects With Chronic Renal Insufficiency (CRI) or End-stage Renal Disease (ESRD) Receiving Dialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-dialysis, End Stage Renal Disease

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    rHuEPO
    Arm Type
    Active Comparator
    Arm Title
    darbepoetin alfa
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    darbepoetin alfa
    Intervention Description
    Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
    Intervention Type
    Drug
    Intervention Name(s)
    rHuEPO
    Intervention Description
    same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL
    Primary Outcome Measure Information:
    Title
    To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis
    Time Frame
    Entire Study
    Secondary Outcome Measure Information:
    Title
    To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD
    Time Frame
    Entire Study

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1 to 18 years of age ESRD receiving dialysis or CRI with eGFR less than 30 mL/min Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete Stable rHuEPO therapy for 8 weeks Exclusion Criteria: Scheduled for a living-related kidney transplant Uncontrolled blood pressure seizure activity Hyperparathyroidism Major surgery within 12 weeks or active inflammatory disease Currently receiving antibiotics Clinical evidence of malignancy Pregnant or breast-feeding
    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
    16724235
    Citation
    Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006 Aug;21(8):1144-52. doi: 10.1007/s00467-006-0071-0. Epub 2006 May 25.
    Results Reference
    result
    Links:
    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/08D_FDAMA_113_Posting_Summary_33_NESP_20000100.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    NESP Pediatric Study

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