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

Association Athletes For Transparency

Status and phase: Unknown; Phase 1

Conditions: Sports Drug Abuse

Treatments: Drug: EPREX; Drug: sodium chloride AGUETTANT 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03276910

Athletes For Transparency

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Eprex 20 UI/kg

Experimental group

Description:

6 doses at 20 IU/kg in subcutaneous use

Treatment:

Drug: EPREX

Eprex 50 UI/kg

Experimental group

Description:

6 doses at 50 IU/kg in subcutaneous use

Treatment:

Drug: EPREX

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: sodium chloride AGUETTANT 0.9%