search
Back to results

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
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Metabolism Disorders

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
May 27, 2008
Last Updated
May 29, 2008
Sponsor
Rennes University Hospital
search

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

We'll reach out to this number within 24 hrs