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Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents (ERYTHROFER-01)

Primary Purpose

Sports Drug Abuse

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
EPREX
sodium chloride AGUETTANT 0.9%
Sponsored by
Association Athletes For Transparency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sports Drug Abuse focused on measuring antidoping

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Man between 18 and 49 years old
  • Beneficiary of a social protection scheme
  • Able to sign informed consent

Exclusion Criteria:

  • Hematocrite>50% or Hemoglobin> 17d/dl or Ferritin<30 ug/l
  • Hypersensitivity to the active substance or to any of the excipients ofEPREX
  • Erythroblastopenia already reported following treatment with erythropoietin
  • Uncontrolled hypertension
  • Any medication taken as part of a chronic treatment
  • Absence of stable or evolutionary pathology without treatment
  • History of convulsion or epilepsy
  • History of thrombotic vascular events
  • Large blood loss due to an accident, pathological condition or other similar situation.
  • Donation of blood or blood transfusion within three months prior to inclusion in the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Eprex 20 UI/kg

    Eprex 50 UI/kg

    Placebo

    Arm Description

    6 doses at 20 IU/kg in subcutaneous use

    6 doses at 50 IU/kg in subcutaneous use

    6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%

    Outcomes

    Primary Outcome Measures

    Erythroferrone
    dosage Erythroferrone from blood samples

    Secondary Outcome Measures

    Hbmass
    Measure of the total mass of hemoglobin

    Full Information

    First Posted
    September 7, 2017
    Last Updated
    September 7, 2017
    Sponsor
    Association Athletes For Transparency
    Collaborators
    University of Milan School of Medicine, Centre d'Investigation Clinique Lyon (CIC), Ecole Nationale de Ski et d'Alpinisme (ENSA), Partnership for Clean Competition
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03276910
    Brief Title
    Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
    Acronym
    ERYTHROFER-01
    Official Title
    Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 8, 2017 (Anticipated)
    Primary Completion Date
    December 22, 2017 (Anticipated)
    Study Completion Date
    June 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Association Athletes For Transparency
    Collaborators
    University of Milan School of Medicine, Centre d'Investigation Clinique Lyon (CIC), Ecole Nationale de Ski et d'Alpinisme (ENSA), Partnership for Clean Competition

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this research is to demonstrate the possible use of erythroferrone (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sports Drug Abuse
    Keywords
    antidoping

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    3 different conditions: Eprex 20 UI/kg Eprex 50 UI/kg Placebo
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Eprex 20 UI/kg
    Arm Type
    Experimental
    Arm Description
    6 doses at 20 IU/kg in subcutaneous use
    Arm Title
    Eprex 50 UI/kg
    Arm Type
    Experimental
    Arm Description
    6 doses at 50 IU/kg in subcutaneous use
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%
    Intervention Type
    Drug
    Intervention Name(s)
    EPREX
    Intervention Description
    6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
    Intervention Type
    Drug
    Intervention Name(s)
    sodium chloride AGUETTANT 0.9%
    Intervention Description
    6 injections at 1ml in subcutaneous use
    Primary Outcome Measure Information:
    Title
    Erythroferrone
    Description
    dosage Erythroferrone from blood samples
    Time Frame
    12 measures in 29 days
    Secondary Outcome Measure Information:
    Title
    Hbmass
    Description
    Measure of the total mass of hemoglobin
    Time Frame
    2 measures in 29 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Man between 18 and 49 years old Beneficiary of a social protection scheme Able to sign informed consent Exclusion Criteria: Hematocrite>50% or Hemoglobin> 17d/dl or Ferritin<30 ug/l Hypersensitivity to the active substance or to any of the excipients ofEPREX Erythroblastopenia already reported following treatment with erythropoietin Uncontrolled hypertension Any medication taken as part of a chronic treatment Absence of stable or evolutionary pathology without treatment History of convulsion or epilepsy History of thrombotic vascular events Large blood loss due to an accident, pathological condition or other similar situation. Donation of blood or blood transfusion within three months prior to inclusion in the protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pierre SALLET, phD
    Phone
    +33661587265
    Email
    p.sallet@athletesfortransparency.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Catherine MD CORNU, phD
    Phone
    +33472357231
    Email
    catherine.cornu@chu-lyon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine MD CORNU, phD
    Organizational Affiliation
    Centre d'Investigation Clinique (CIC)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

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