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

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ClinicalTrials.gov Identifier: NCT00687518
Recruitment Status : Unknown
Verified May 2008 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2008
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:
Rennes University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Iron Metabolism Disorders Drug: Erythropoietin Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
Study Start Date : March 2008
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
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%




Primary Outcome Measures :
  1. serum hepcidin levels [ Time Frame: over 24 hours ]

Secondary Outcome Measures :
  1. urinary hepcidin levels [ Time Frame: over 24 hours ]
  2. serum iron and ferritin levels [ Time Frame: over 24 hours ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Metabolic Diseases
Iron Metabolism Disorders
Epoetin Alfa
Hepcidins
Hematinics
Anti-Infective Agents