Iron Metabolism DisordersHEPEPONCT00687518
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
A study testing Erythropoietin in people with Iron Metabolism Disorders, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Metabolism Disorders
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2008to 30 Sep 2008
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- male aged 18 - 30
- normal routine laboratory values
- normal ECG
- normal iron status
Who cannot join
- C282Y mutation of the HFE gene
- alcohol or tobacco consumption
Trial locations and contacts
1 site in 1 country.
France1 site
Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, 35033
About this study
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.
- Conditions
- Iron Metabolism Disorders
- Being tested
- Erythropoietin, Placebo
- Medical subject headings
- Iron Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called Neorecormon®
Intravenous injection of 50 U/kg of erythropoietin
PlaceboDrug
Also called NaCl 0,9%
Intravenous injection of equivalent volume of saline serum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | erythropoietin Receives: Drug: Erythropoietin |
| 2 | Placebo comparator | Saline serum Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum hepcidin levels
Measured: over 24 hours
Secondary outcomes (2)
urinary hepcidin levels
Measured: over 24 hours
serum iron and ferritin levels
Measured: over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study start7 Feb 2008
- Primary completion30 Sep 2008
- Study completion30 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice LAINE, MD, Principal investigator, Rennes University HospitalBruno LAVIOLLE, MD, Study chair, RennesUniversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687518
- Sponsor's protocol ID
- DGS 2006/0416
- Other IDs
- CIC0203/056
- Acronym
- HEPEPO
- Status last verified
- Sep 2009
- First submitted
- 27 May 2008
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21818622