Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Association Athletes For Transparency
• Collaborators: Centre d'Investigation Clinique Lyon (CIC); Ecole Nationale de Ski et d'Alpinisme (ENSA); Partnership for Clean Competition; University of Milan School of Medicine
• Treatments: Epoetin Alfa

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.