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

Sponsor
Rennes University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00687518
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
11.1
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2008
Anticipated Primary Completion Date :
Nov 1, 2008
Anticipated Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

erythropoietin

Drug: Erythropoietin
Intravenous injection of 50 U/kg of erythropoietin
Other Names:
  • Neorecormon®

    		•
    Placebo Comparator: 2

    Saline serum

    Drug: Placebo
    Intravenous injection of equivalent volume of saline serum
    Other Names:
  • NaCl 0,9%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum hepcidin levels [over 24 hours]

    Secondary Outcome Measures

    1. urinary hepcidin levels [over 24 hours]

    2. serum iron and ferritin levels [over 24 hours]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou Rennes France 35033

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    • Principal Investigator: Fabrice LAINE, MD, Rennes University Hospital
    • Study Chair: Bruno LAVIOLLE, MD, RennesUniversity Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00687518
    Other Study ID Numbers:
    • DGS 2006/0416
    • CIC0203/056
    First Posted:
    May 30, 2008
    Last Update Posted:
    May 30, 2008
    Last Verified:
    May 1, 2008
    Additional relevant MeSH terms:
    Metabolic Diseases
    Iron Metabolism Disorders
    Epoetin Alfa

    Study Results

    No Results Posted as of May 30, 2008