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

Sponsor
Association Athletes For Transparency (Other)
Overall Status
Unknown status
CT.gov ID
NCT03276910
Collaborator
University of Milan School of Medicine (Other), Centre d'Investigation Clinique Lyon (CIC) (Other), Ecole Nationale de Ski et d'Alpinisme (ENSA) (Other), Partnership for Clean Competition (Other)
24
Enrollment
3
Arms
8.7
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3 different conditions: Eprex 20 UI/kg Eprex 50 UI/kg Placebo3 different conditions: Eprex 20 UI/kg Eprex 50 UI/kg Placebo
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
Anticipated Study Start Date :
Sep 8, 2017
Anticipated Primary Completion Date :
Dec 22, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eprex 20 UI/kg

6 doses at 20 IU/kg in subcutaneous use

Drug: EPREX
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
Experimental: Eprex 50 UI/kg

6 doses at 50 IU/kg in subcutaneous use

Drug: EPREX
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
Placebo Comparator: Placebo

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

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

Outcome Measures

Primary Outcome Measures

  1. Erythroferrone [12 measures in 29 days]

    dosage Erythroferrone from blood samples

Secondary Outcome Measures

  1. Hbmass [2 measures in 29 days]

    Measure of the total mass of hemoglobin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Association Athletes For Transparency
  • University of Milan School of Medicine
  • Centre d'Investigation Clinique Lyon (CIC)
  • Ecole Nationale de Ski et d'Alpinisme (ENSA)
  • Partnership for Clean Competition

Investigators

  • Principal Investigator: Catherine MD CORNU, phD, Centre d'Investigation Clinique (CIC)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Association Athletes For Transparency
ClinicalTrials.gov Identifier:
NCT03276910
Other Study ID Numbers:
  • Athletes For Transparency
First Posted:
Sep 8, 2017
Last Update Posted:
Sep 8, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Association Athletes For Transparency
antidoping
Additional relevant MeSH terms:
Substance-Related Disorders

Study Results

No Results Posted as of Sep 8, 2017