Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers (HEPEPO)
Primary Purpose
Iron Metabolism Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Erythropoietin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Iron Metabolism Disorders
Eligibility 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
Sites / Locations
- Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de PontchaillouRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
erythropoietin
Saline serum
Outcomes
Primary Outcome Measures
serum hepcidin levels
Secondary Outcome Measures
urinary hepcidin levels
serum iron and ferritin levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687518
Brief Title
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
Acronym
HEPEPO
Official Title
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Metabolism Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
erythropoietin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Saline serum
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Other Intervention Name(s)
Neorecormon®
Intervention Description
Intravenous injection of 50 U/kg of erythropoietin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl 0,9%
Intervention Description
Intravenous injection of equivalent volume of saline serum
Primary Outcome Measure Information:
Title
serum hepcidin levels
Time Frame
over 24 hours
Secondary Outcome Measure Information:
Title
urinary hepcidin levels
Time Frame
over 24 hours
Title
serum iron and ferritin levels
Time Frame
over 24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice LAINE, MD
Phone
33-2-9928-9199
Email
fabrice.laine@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice LAINE, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno LAVIOLLE, MD
Organizational Affiliation
RennesUniversity Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice LAINE, MD
Phone
33-2-9928-9199
Email
fabrice.laine@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Fabrice LAINE, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21818622
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
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