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

Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers (HEPEPO)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Rennes University Hospital. Recruitment status was Recruiting

First Received on May 27, 2008. Last Updated on May 29, 2008 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Iron Metabolic Disorders

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

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
Experimental: 1 erythropoietin	Drug: Erythropoietin Intravenous injection of 50 U/kg of erythropoietin Other Name: Neorecormon®
Placebo Comparator: 2 Saline serum	Drug: Placebo Intravenous injection of equivalent volume of saline serum Other Name: NaCl 0,9%

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

No publications provided

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

Additional relevant MeSH terms:

Iron Metabolism Disorders
Metabolic Diseases
Epoetin Alfa
Hematinics

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012