Sports Drug AbusePhase 1ERYTHROFER-01NCT03276910
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
A Phase 1 study testing EPREX and sodium chloride AGUETTANT 0.9% in people with Sports Drug Abuse, run by Association Athletes For Transparency.
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). Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Drug Abuse
- What is being tested?
- EPREX and sodium chloride AGUETTANT 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2017to 1 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man between 18 and 49 years old
- Beneficiary of a social protection scheme
- Able to sign informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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).
- Conditions
- Sports Drug Abuse
- Being tested
- EPREX, sodium chloride AGUETTANT 0.9%
- Keywords
- antidoping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPREXDrug
6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
sodium chloride AGUETTANT 0.9%Drug
6 injections at 1ml in subcutaneous use
| Study group | Role | What they receive |
|---|---|---|
| Eprex 20 UI/kg | Experimental | 6 doses at 20 IU/kg in subcutaneous use Receives: Drug: EPREX |
| Eprex 50 UI/kg | Experimental | 6 doses at 50 IU/kg in subcutaneous use Receives: Drug: EPREX |
| Placebo | Placebo comparator | 6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9% Receives: Drug: sodium chloride AGUETTANT 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythroferrone
dosage Erythroferrone from blood samples
Measured: 12 measures in 29 days
Secondary outcomes (1)
Hbmass
Measure of the total mass of hemoglobin
Measured: 2 measures in 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start8 Sep 2017 (estimated)
- Primary completion22 Dec 2017 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 different conditions: * Eprex 20 UI/kg * Eprex 50 UI/kg * Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Athletes For Transparency
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan School of Medicine, Centre d'Investigation Clinique Lyon (CIC), Ecole Nationale de Ski et d'Alpinisme (ENSA), Partnership for Clean Competition
- Responsible party
- Sponsor
- Investigators
- Catherine MD CORNU, phD, Principal investigator, Centre d'Investigation Clinique (CIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276910
- Sponsor's protocol ID
- Athletes For Transparency
- Acronym
- ERYTHROFER-01
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
- ClinicalTrials.gov ID
- NCT03276910
- Acronym / sponsor ID
- ERYTHROFER-01 / Athletes For Transparency
- Conditions
- Sports Drug Abuse
- Keywords
- antidoping
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Association Athletes For TransparencyUniversity, hospital or other
- Collaborators
- University of Milan School of Medicine, Centre d'Investigation Clinique Lyon (CIC), Ecole Nationale de Ski et d'Alpinisme (ENSA), Partnership for Clean Competition
- Study start
- 8 Sep 2017 (estimated)
- Primary completion
- 22 Dec 2017 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 different conditions: * Eprex 20 UI/kg * Eprex 50 UI/kg * Placebo
| Arm | Type | Receives |
|---|---|---|
| Eprex 20 UI/kg | Experimental | Drug: EPREX6 doses at 20 IU/kg in subcutaneous use |
| Eprex 50 UI/kg | Experimental | Drug: EPREX6 doses at 50 IU/kg in subcutaneous use |
| Placebo | Placebo comparator | Drug: sodium chloride AGUETTANT 0.9%6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9% |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Man between 18 and 49 years old
- Beneficiary of a social protection scheme
- Able to sign informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPREX6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use | Drug | Eprex 20 UI/kg, Eprex 50 UI/kg |
| sodium chloride AGUETTANT 0.9%6 injections at 1ml in subcutaneous use | Drug | Placebo |
Primary outcome
Erythroferrone
Time frame: 12 measures in 29 days
dosage Erythroferrone from blood samples
1 secondary outcome
Hbmass
Time frame: 2 measures in 29 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine MD CORNU, phD principal investigator
Centre d'Investigation Clinique (CIC)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPREX and sodium chloride AGUETTANT 0.9% in people with Sports Drug Abuse, run by Association Athletes For Transparency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre SALLET, phD (+33661587265, p.sallet@athletesfortransparency.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythroferrone (time frame: 12 measures in 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.