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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Rennes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00687518
First received: May 27, 2008
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

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 Intervention
Iron Metabolism Disorders
Drug: Erythropoietin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • serum hepcidin levels [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary hepcidin levels [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]
  • serum iron and ferritin levels [ Time Frame: over 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: March 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Rennes University Hospital

Additional 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
Study First Received: May 27, 2008
Last Updated: May 29, 2008
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Iron Metabolism Disorders
Metabolic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014