Evaluation of Erythroferrone as a New Biomarker of Erythr... | NCT03276910

Studies
Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents

NCT03276910

Sponsor

Association Athletes For Transparency

Status

Unknown status

Last Update Posted

Sep 8, 2017Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Sports Drug Abuse

Interventions

EPREX
sodium chloride AGUETTANT 0.9%

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2017Estimated

Primary Completion Date

Dec 22, 2017Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Sep 7, 2017

First Submission Date that Met QC Criteria

Sep 7, 2017

First Posted Date

Sep 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2017

Last Update Posted Date

Sep 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Association Athletes For TransparencyOTHER

Collaborators

Name	Class
University of Milan School of Medicine	UNKNOWN
Centre d'Investigation Clinique Lyon (CIC)	UNKNOWN
Ecole Nationale de Ski et d'Alpinisme (ENSA)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eprex 20 UI/kg	Experimental	6 doses at 20 IU/kg in subcutaneous use	Drug: EPREX
Eprex 50 UI/kg	Experimental	6 doses at 50 IU/kg in subcutaneous use	Drug: EPREX
Placebo	Placebo Comparator	6 injections at 1ml in subcutaneous use of sodium chloride AGUETTANT 0.9%	Drug: sodium chloride AGUETTANT 0.9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EPREX	Drug	6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use	Eprex 20 UI/kg Eprex 50 UI/kg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre SALLET, phD	Contact	+33661587265		p.sallet@athletesfortransparency.com
Catherine MD CORNU, phD	Contact	+33472357231		catherine.cornu@chu-lyon.fr

Overall Officials

Name	Affiliation	Role
Catherine MD CORNU, phD	Centre d'Investigation Clinique (CIC)	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068817	Epoetin Alfa

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided