Female first-time bloddonors with iron deficiency MedDRA version: 18.1 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Monofer
Product Name: Monofer
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Iron Isomaltoside 1000
CAS Number: 9004-66-4
Other descriptive name: Iron oligosaccharide comp
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in the study if they fulfil the following criteria: 1. Women aged = 18 years 2. First-time donor 3. P-ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if they fulfil any of the following criteria: 1. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemo-siderosis) 2. Known hypersensitivity to any excipients in the investigational drug products 3. History of drug related allergies 4. History of severe asthma 5. Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal) 6. Active acute or chronic infections (assessed by clinical judgement supplied with WBC and CRP) 7. Rheumatoid arthritis with symptoms or signs of active inflammation 8. Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product 9. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening 10. Untreated vitamin B12 or folate deficiency 11. Treated with other IV or oral iron products within 4 weeks prior to the screening 12. Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo in first-time female donors with p-ferritin below 60 µg/L. The safety objective of the study is to evaluate the safety of IV iron isomaltoside 1000 compared to placebo.;Secondary Objective: The secondary efficacy objectives are to evaluate the effect of iron isomaltoside 1000 compared with placebo on: • Change in Hb concentration • Tolerance of three blood donations • Other relevant iron related biochemical parameters • Fatigue • Restless Legs Syndrome (RLS) symptoms • Exercise tolerance ;Primary end point(s): The primary endpoint of the study is to measure and compare the change in Hb concentration from baseline to right before the third blood donation in the two study arms. The safety endpoint includes: • Type and incidence of adverse drug reactions (ADRs) • 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 • Change in vital signs (heart rate and blood pressure) from baseline to 12 weeks after first and second blood donation • Change in electrocardiogram (ECG) from baseline to 12 weeks after second blood donation • Change in weight from baseline to 12 weeks after second blood donation • Change in physical condition from screening to 12 weeks after second blood donation ;Timepoint(s) of evaluation of this end point: 3-6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3-6 months;Secondary end point(s): The secondary endpoints are to measure and compare the following in the two study arms: • Change in Hb concentrations from baseline to right before second donation • Number of subjects who cannot tolerate three donations due to cHb < LA • 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 • Change in fatigue symptoms from baseline to 12 weeks after first and second blood donation measured by the Fatigue Visual Numeric Scale and five questions from the Fatigue Severity Scale (FSS) • Change in RLS symptoms from baseline to 12 weeks after first and second blood do-nation measured by the Cambridge-Hopkins Restless Legs Syndrome questionnaire (CH-RLSq) • Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike | — |
Countries
Denmark
Contacts
Public ContactClinical R & D
Pharmacosmos A/S
Outcome results
None listed