Subjects with iron deficiency anaemia (IDA) caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy. MedDRA version: 17.1 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system
Conditions
Interventions
Trade Name: Monofer
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iron Isomaltoside 1000
CAS Number: 1370654-58-2
Other descriptive name: IRON ISOMALTOSIDE 1000
Concentration unit:
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in the study if he/she fulfils the following criteria: 1. Men or women = 18 years having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy** for at least one month*** prior to study enrolment 2. Hb =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if he/she fulfils any of the following criteria: 1. Hb 3 times upper limit of normal) 5. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP)) 6. Body weight < 50 kg 7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing 8. History of multiple allergies 9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products 10. Erythropoietin treatment within 8 weeks prior to the screening visit 11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit 12. Participation in any other interventional clinical study within 3 months prior to the screening visit 13. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischaemic heart dis-ease, or uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.;Secondary Objective: The secondary objectives are to compare the effect of iron isomaltoside 1000 and placebo on: • Other relevant iron related biochemical parameters • Fatigue symptoms • Restless leg syndrome (RLS) symptoms • QoL The safety objective of the study is to evaluate the safety of iron isomaltoside 1000 compared to placebo. ;Primary end point(s): • Proportion of subjects with an Hb increase of = 2 g/dL from baseline at any time from week 1 to week 5;Timepoint(s) of evaluation of this end point: Any time between week 1 and week 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to Hb = 2 g/dL • Number of subjects who achieve Hb levels of > 12 g/dL • Number of subjects who achieve a serum (s-) ferritin increase of at least 100 ng/mL; or achieve a transferrin saturation (TSAT) of 20-50 % at week 2, 4, or 5 • Change in Hb concentration from baseline to week 2, 4, and 5 • Change in concentrations of s-ferritin, TSAT, and s-iron from baseline to week 1, 2, 4, and 5 • Change in fatigue symptoms from baseline to week 2 and 5 measured by the Func-tional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale • Change in RLS symptoms from baseline to week 5 measured by the Cambridge-Hopkins RLS questionnaire (CH-RLSq) • Change in QoL from baseline to week 2 and 5 measured by Short Form (SF)-36 ques-tionnaires • Type and incidence of adverse drug reactions (ADRs) • Number of adverse events (AEs) of special interest (i.e. hypersensitivity symptoms such as: urticaria, oedema, bronchospasm, hypotension, cardiorespiratory arrest, syn-cope, unresponsiveness, or loss of consciousness at pre-specified time points in rela-tion to administration of study drug) • Change in haematology parameters, s-sodium, s-potassium, s-calcium, s-phosphate, s-urea, s-creatinine, s-albumin, s-bilirubin, aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) from baseline to week 1, 2, 3, 4, and 5 • Change in vital signs (heart rate and blood pressure) from baseline to each visit • Change in electrocardiogram (ECG) from baseline to peri-infusion and week 5;Timepoint(s) of evaluation of this end point: Please see secondary end points for details. | — |
Countries
Germany, Russian Federation, United Kingdom, United States
Contacts
Public ContactClinical Research & Development
Pharmacosmos A/S
Outcome results
None listed