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

June 11, 2026 updated by: Rennes University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum hepcidin levels
Time Frame: over 24 hours
over 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
urinary hepcidin levels
Time Frame: over 24 hours
over 24 hours
serum iron and ferritin levels
Time Frame: over 24 hours
over 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 7, 2008

Primary Completion (Actual)

September 30, 2008

Study Completion (Actual)

September 30, 2008

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimated)

May 30, 2008

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 2006/0416
  • CIC0203/056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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