Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
ERYTHROFER-01
1 other identifier
interventional
24
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2017
CompletedFirst Posted
Study publicly available on registry
September 8, 2017
CompletedStudy Start
First participant enrolled
September 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 8, 2017
September 1, 2017
4 months
September 7, 2017
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Erythroferrone
dosage Erythroferrone from blood samples
12 measures in 29 days
Secondary Outcomes (1)
Hbmass
2 measures in 29 days
Study Arms (3)
Eprex 20 UI/kg
EXPERIMENTAL6 doses at 20 IU/kg in subcutaneous use
Eprex 50 UI/kg
EXPERIMENTAL6 doses at 50 IU/kg in subcutaneous use
Placebo
PLACEBO COMPARATOR6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%
Interventions
Eligibility Criteria
You may qualify if:
- Man between 18 and 49 years old
- Beneficiary of a social protection scheme
- Able to sign informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Association Athletes For Transparencylead
- University of Milan School of Medicinecollaborator
- Centre d'Investigation Clinique Lyon (CIC)collaborator
- Ecole Nationale de Ski et d'Alpinisme (ENSA)collaborator
- Partnership for Clean Competitioncollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine MD CORNU, phD
Centre d'Investigation Clinique (CIC)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2017
First Posted
September 8, 2017
Study Start
September 8, 2017
Primary Completion
December 22, 2017
Study Completion
June 1, 2018
Last Updated
September 8, 2017
Record last verified: 2017-09