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

September 7, 2017 updated by: Association Athletes For Transparency
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Eprex 20 UI/kg
6 doses at 20 IU/kg in subcutaneous use
Drug: EPREX
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
EXPERIMENTAL: Eprex 50 UI/kg
6 doses at 50 IU/kg in subcutaneous use
Drug: EPREX
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
PLACEBO_COMPARATOR: Placebo
6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%
Drug: sodium chloride AGUETTANT 0.9%
6 injections at 1ml in subcutaneous use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythroferrone
Time Frame: 12 measures in 29 days
dosage Erythroferrone from blood samples
12 measures in 29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hbmass
Time Frame: 2 measures in 29 days
Measure of the total mass of hemoglobin
2 measures in 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Athletes For Transparency

Collaborators

Partnership for Clean Competition
University of Milan School of Medicine
Centre d'Investigation Clinique Lyon (CIC)
Ecole Nationale de Ski et d'Alpinisme (ENSA)

Investigators

  • Principal Investigator: Catherine MD CORNU, phD, Centre d'Investigation Clinique (CIC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 8, 2017

Primary Completion (ANTICIPATED)

December 22, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (ACTUAL)

September 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Athletes For Transparency

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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