MedDataX Logo

Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

NCT ID: NCT00687518

Last Updated: 2008-05-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Metabolism Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

erythropoietin

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type DRUG

Intravenous injection of 50 U/kg of erythropoietin

2

Saline serum

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous injection of equivalent volume of saline serum

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erythropoietin

Intravenous injection of 50 U/kg of erythropoietin

Intervention Type DRUG

Placebo

Intravenous injection of equivalent volume of saline serum

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neorecormon® NaCl 0,9%

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy volunteers
* male aged 18 - 30
* normal routine laboratory values
* normal ECG
* normal iron status

Exclusion Criteria

* C282Y mutation of the HFE gene
* alcohol or tobacco consumption
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rennes University Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fabrice LAINE, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Bruno LAVIOLLE, MD

Role: STUDY_CHAIR

RennesUniversity Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou

Rennes, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fabrice LAINE, MD

Role: CONTACT

Phone: 33-2-9928-9199

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fabrice LAINE, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Laine F, Laviolle B, Ropert M, Bouguen G, Morcet J, Hamon C, Massart C, Westermann M, Deugnier Y, Loreal O. Early effects of erythropoietin on serum hepcidin and serum iron bioavailability in healthy volunteers. Eur J Appl Physiol. 2012 Apr;112(4):1391-7. doi: 10.1007/s00421-011-2097-7. Epub 2011 Aug 5.

Reference Type DERIVED
PMID: 21818622 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIC0203/056

Identifier Type: -

Identifier Source: secondary_id

DGS 2006/0416

Identifier Type: -

Identifier Source: org_study_id