Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
- Registration Number
- NCT03276910
- Lead Sponsor
- Association Athletes For Transparency
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eprex 50 UI/kg EPREX 6 doses at 50 IU/kg in subcutaneous use Placebo sodium chloride AGUETTANT 0.9% 6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9% Eprex 20 UI/kg EPREX 6 doses at 20 IU/kg in subcutaneous use
- Primary Outcome Measures
Name Time Method Erythroferrone 12 measures in 29 days dosage Erythroferrone from blood samples
- Secondary Outcome Measures
Name Time Method Hbmass 2 measures in 29 days Measure of the total mass of hemoglobin