A randomized, double-blind comparative study comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for iron substitution in iron-deficiency anemia
- Conditions
- MedDRA - 10002062 (Anaemia iron deficiency)ICD 10: D50D50Iron deficiency anaemia
- Registration Number
- DRKS00010766
- Lead Sponsor
- niversität des Saarlandes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 26
• Written informed consent,
• female,
• gynecological blood losses,
• Age = 18 years,
• iron deficiency anemia,
• Hemoglobin < 12,0 g/dl,
• Serum-Ferritin = 100 ng/ml or Serum-Ferritin = 300 ng/ml and Transferrin-saturation = 30 %,
• Intolerance to or inefficacy of an oral iron supplement
• eGFR > 15 ml/min/1.73 m²
• Known hypersensitivity to MonoFer® or FERINJECT®,
• severe, known hypersensitivity to other intravenous iron preparations,
• Plasma Phosphate < 2.5 mg/dl at screening,
• Hemochromatosis,
• Untreated hyperparathyreoidism,
• Renal replacement therapy/kidney transplantation,
• Active malignant disease, disease-free survival for less than 5 years,
• Intravenous iron administration within the last 30 days,
• Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
• Surgery under anesthetic within the last 10 days,
• Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
• Acute febrile infections within the last 7 days,
• Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
• self-reported severe asthma or eczema,
• presence of further relative contraindications (any allergy, any immunologic or inflammatory diseases, history of atopic allergies), which, according the assessment of the investigator, appear to be a contraindication for the treatment with one of the investigational medicinal products,
• pregnancy,
• women of childbearing potential without an effective method of contraception,
• lactating women,
• Present alcohol or drug dependency,
• Patients with a history of a psychological illness or seizures,
• Non-compliance or administration of any investigational drug within 30 days preceding the study start;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method aboratroy test to control if plasma-phosphate declines below 2.0 mg/dl on the following time-points:<br>1. one measurement 1 day after administration of the iron-compound,<br>2. one measurement in the time period 5 to 9 days after administration of the iron compound,<br>3. one measurement in the time period 33 to 37 days after administration of the iron compound.
- Secondary Outcome Measures
Name Time Method To compare the effects of iron substitution with either ferric carboxymaltose or iron isomaltoside 1000 in patients with irondeficiency anemia on<br>(1) Plasma phosphate (absolute [?] and relative [%] changes),<br>(2) Fractional phosphate urinary excretion,<br>(3) Plasma vitamin D (active, inactive),<br>(4) Plasma fibroblast growth factor (FGF-23) (intact und c-terminal),<br>(5) Plasma parathyroid hormone (PTH)<br>(6) Calcium level<br>(7) Plasma Alkaline Phosphatase<br>(8) Plasma soluble Klotho<br>(9) Plasma Hepcidine-25<br>(10) Serum N-Terminal Propeptide of Type I Collagen (PINP)<br>(11) Pyridinoline (PYD) in the urine<br>(12) Quality of life and<br>(13) Electrophysiological changes, quantified as<br>a. incidence of cardiac arrhythmias in 24 hour ambulatory ECG,<br>b. QT-time in 12-lead ECG and<br>c. QT-dispersion in 12-lead ECG.<br>(14) Echocardiography<br>(15) Monocyte subpopulations