Skip to main content
. 2014 Jul 3;2014(7):CD009532. doi: 10.1002/14651858.CD009532.pub2

EUCTR2012‐001529‐28‐DK.

Trial name or title A randomized, prospective, double‐blind, comparative placebo‐controlled study of intravenous iron isomaltoside 1000 (Monofer®) administered by infusions to iron‐deficient blood donors
Methods A phase 3, randomised, double‐blind, parallel, safety/efficacy study
Participants Female blood donors:

  • Aged ≥ 18 years

  • First‐time donor

  • P‐ferritin < 30 µg/L

  • Willingness to participate and signed the informed consent form
Interventions Treatment arm 1: intravenous iron oligosaccharide complex: Monofer®
Treatment arm 2: intravenous placebo infusion
Outcomes Primary outcome:

  1. Change in Hb concentration from baseline to right before the third blood donation in the 2 study arms

  2. Type and incidence of adverse drug reactions (ADRs)

  3. Change in haematology parameters, p‐sodium, p‐potassium, p‐calcium, p‐phosphate, p‐urea, p‐creatinine, p‐albumin, p‐bilirubin, and Alanine Aminotransferase (ALAT) from baseline to 12 weeks after first and second blood donation

  4. Change in vital signs (heart rate and blood pressure) from baseline to 12 weeks after first and second blood donation

  5. Change in electrocardiogram (ECG) from baseline to 12 weeks after second blood donation

  6. Change in weight from baseline to 12 weeks after second blood donation

  7. Change in physical condition from screening to 12 weeks after second blood donation


Secondary outcomes:

  1. Change in Hb concentrations from baseline to right before second donation

  2. Number of subjects who cannot tolerate 3 donations due to low Hb

  3. Change in concentrations of p‐iron, p‐ferritin, transferrin saturation (TSAT) and re‐ticulocyte count from baseline to 12 weeks after first and second blood donation

  4. Change in fatigue symptoms from baseline to 12 weeks after first and second blood donation measured by the Fatigue Visual Numeric Scale and 5 questions from the Fatigue Severity Scale (FSS)

  5. Change in RLS symptoms from baseline to 12 weeks after first and second blood donation measured by the Cambridge‐Hopkins Restless Legs Syndrome questionnaire (CH‐RLSq)

  6. Change in exercise tolerance from baseline to 3 weeks after baseline measured by a 2‐step test on bike
Starting date June 2012
Contact information Clinical R&D, Pharmacosmos CRO, Rørvangsvej 30, Holbæk, 4300, Denmark. Email: llt@pharmacosmos.com
Notes Sponsored by Pharmacosmos A/S. This trial is ongoing