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

Not Applicable

• Conditions: Iron Metabolism Disorders
• Interventions: Drug: Placebo; Drug: Erythropoietin

• Registration Number: NCT00687518
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2008-05
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Last Update Submitted: 2008-05-29
• Study First Posted: 2008-05-30
• Last Update Posted: 2008-05-30
• Primary Completion: 2008-11
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	Saline serum
1	Erythropoietin	erythropoietin

Primary Outcome Measures

Name	Time	Method
serum hepcidin levels	over 24 hours

Secondary Outcome Measures

Name	Time	Method
urinary hepcidin levels	over 24 hours
serum iron and ferritin levels	over 24 hours

Trial Locations

Locations (1)

Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou; 🇫🇷 Rennes, France