Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

Sports Drug Abuse Clinical Trial

— ERYTHROFER-01  

Official title:

Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03276910
• Other study ID #: Athletes For Transparency
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 7, 2017
• Last updated: September 7, 2017
• Start date: September 8, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2017
• Source: Association Athletes For Transparency
• Contact: Pierre SALLET, phD
• Phone: +33661587265
• Email: p.sallet[@]athletesfortransparency.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 1, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sports Drug Abuse
• Substance-Related Disorders

Intervention

Drug:
• EPREX
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
• sodium chloride AGUETTANT 0.9%
6 injections at 1ml in subcutaneous use

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythroferrone	dosage Erythroferrone from blood samples	12 measures in 29 days
Secondary	Hbmass	Measure of the total mass of hemoglobin	2 measures in 29 days