Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention
Iron Metabolism Disorders	Drug: Erythropoietin Drug: Placebo

MedlinePlus related topics:

Metabolic Disorders

ChemIDplus related topics:

Epoetin alfa Erythropoietin Epoetin beta Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Official Title:	Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

serum hepcidin levels [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

urinary hepcidin levels [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]
serum iron and ferritin levels [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental erythropoietin	Drug: Erythropoietin Intravenous injection of 50 U/kg of erythropoietin
2: Placebo Comparator Saline serum	Drug: Placebo Intravenous injection of equivalent volume of saline serum

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687518

Contacts


Contact: Fabrice LAINE, MD	33-2-9928-9199	fabrice.laine@chu-rennes.fr

Locations


France
	Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou	Recruiting
	Rennes, France, 35033
	Contact: Fabrice LAINE, MD 33-2-9928-9199 fabrice.laine@chu-rennes.fr
	Principal Investigator: Fabrice LAINE, MD

Sponsors and Collaborators

Rennes University Hospital

Investigators


Principal Investigator:	Fabrice LAINE, MD	Rennes University Hospital

Study Chair:	Bruno LAVIOLLE, MD	RennesUniversity Hospital

More Information

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research and Strategy )
Study ID Numbers:	DGS 2006/0416, CIC0203/056
First Received:	May 27, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00687518
Health Authority:	France: Direction Générale de la Santé

Study placed in the following topic categories:

Epoetin Alfa

Metabolic Diseases

Healthy

Iron Metabolism Disorders

Metabolic disorder

Additional relevant MeSH terms:

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Rennes University Hospital
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00687518