A clinical open, randomised study of oral iron (Duroferon®) vs. intravenous iron (Ferinject®) for iron substitution in blood donors.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010623-64-SE

Enrollment

210

Registered

2009-02-19

Start date

2009-04-02

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency. MedDRA version: 9.1 Level: LLT Classification code 10022972 Term: Iron deficiency anaemia MedDRA version: 9.1 Level: LLT Classification code 10022975 Term: Iron deficiency anemia secondary to blood loss (chronic)

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Injection* INN or Proposed INN: Ferric carboxymaltose Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • Anaemia not attributable to iron deficiency, e.g. other type of microcytic anaemia. • Iron overload. • Contraindications for Ferinject® or Duroferon®. • Contraindications for blood donations.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether there is a difference in the change of blood haemoglobin (Hb) levels between blood donors receiving intravenous iron (Ferinject®) vs. the Swedish standard iron substitution regimen of oral iron (Duroferon®) at visit 2, compared to baseline. ;Secondary Objective: To investigate whether there is a difference in the change of blood Hb levels at the 3rd, 4th and 5th whole blood donation (males), and at the 3rd and 4th donation (females) between blood donors receiving intravenous iron (Ferinject®) vs. the Swedish standard iron substitution regimen oral iron (Duroferon®). To compare the two treatment groups regarding effects on iron status, health status (SF-36), International RLS Study Group Rating Scale (IRLS) score, and fatigue status after respective blood donation and after 1 year, i.e. after totally five donations in males and four donations in females . To compare the two treatments regarding incidences and severities of adverse events, tolerance and compliance. ;Primary end point(s): Primary efficacy variable: Change in blood Hb analysed at the second blood donation.	—

Measure

Time frame

Main Objective: To investigate whether there is a difference in the change of blood haemoglobin (Hb) levels between blood donors receiving intravenous iron (Ferinject®) vs. the Swedish standard iron substitution regimen of oral iron (Duroferon®) at visit 2, compared to baseline. ;Secondary Objective: To investigate whether there is a difference in the change of blood Hb levels at the 3rd, 4th and 5th whole blood donation (males), and at the 3rd and 4th donation (females) between blood donors receiving intravenous iron (Ferinject®) vs. the Swedish standard iron substitution regimen oral iron (Duroferon®). To compare the two treatment groups regarding effects on iron status, health status (SF-36), International RLS Study Group Rating Scale (IRLS) score, and fatigue status after respective blood donation and after 1 year, i.e. after totally five donations in males and four donations in females . To compare the two treatments regarding incidences and severities of adverse events, tolerance and compliance. ;Primary end point(s): Primary efficacy variable: Change in blood Hb analysed at the second blood donation.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026