A clinical open, randomised study of oral iron (Duroferon®) vs. intravenous iron (Ferinject®) for iron substitution in blood donors.
- Conditions
- Iron deficiency.MedDRA version: 9.1Level: LLTClassification code 10022972Term: Iron deficiency anaemiaMedDRA version: 9.1Level: LLTClassification code 10022975Term: Iron deficiency anemia secondary to blood loss (chronic)
- Registration Number
- EUCTR2009-010623-64-SE
- Lead Sponsor
- Renapharma AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 210
•Males and females qualified as whole blood donors .
•Fulfilled at least 5 previous whole blood donations.
•Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Anaemia not attributable to iron deficiency, e.g. other type of microcytic anaemia.
•Iron overload.
•Contraindications for Ferinject® or Duroferon®.
•Contraindications for blood donations.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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