UnknownPhase 1

Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

24 participantsStarted 2017-09-08

Plain-language 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).

Who can participate

Age range

18 Years – 49 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Erythroferrone

Timeframe: 12 measures in 29 days

Trial details

NCT IDNCT03276910

SponsorAssociation Athletes For Transparency

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-22

Contact for this trial

Pierre SALLET, phD

+33661587265 p.sallet@athletesfortransparency.com

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