Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-08

Study Completion Date

2018-06-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Sports Drug Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 different conditions:

* Eprex 20 UI/kg
* Eprex 50 UI/kg
* Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Eprex 20 UI/kg

6 doses at 20 IU/kg in subcutaneous use

Group Type EXPERIMENTAL

EPREX

Intervention Type DRUG

6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use

Eprex 50 UI/kg

6 doses at 50 IU/kg in subcutaneous use

Group Type EXPERIMENTAL

EPREX

Intervention Type DRUG

6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use

Placebo

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

Group Type PLACEBO_COMPARATOR

sodium chloride AGUETTANT 0.9%

Intervention Type DRUG

6 injections at 1ml in subcutaneous use

Interventions

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EPREX

6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use

Intervention Type DRUG

sodium chloride AGUETTANT 0.9%

6 injections at 1ml in subcutaneous use

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes