MedDRA - 10002062 (Anaemia iron deficiency)
Conditions
Interventions
Group 1: Investigation of plasma-phosphate after treatment of iron deficiency anemia with Iron isomaltoside 1000 (Monofer). Unique intravenous application of 20 mg per kilogram bodyweight, but not mor
Sponsors
Universität des Saarlandes
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Written informed consent, • female, • gynecological blood losses, • Age = 18 years, • iron deficiency anemia, • Hemoglobin 15 ml/min/1.73 m²
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to MonoFer® or FERINJECT®, • severe, known hypersensitivity to other intravenous iron preparations, • Plasma Phosphate 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratroy test to control if plasma-phosphate declines below 2.0 mg/dl on the following time-points: 1. one measurement 1 day after administration of the iron-compound, 2. one measurement in the time period 5 to 9 days after administration of the iron compound, 3. one measurement in the time period 33 to 37 days after administration of the iron compound. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effects of iron substitution with either ferric carboxymaltose or iron isomaltoside 1000 in patients with irondeficiency anemia on (1) Plasma phosphate (absolute [?] and relative [%] changes), (2) Fractional phosphate urinary excretion, (3) Plasma vitamin D (active, inactive), (4) Plasma fibroblast growth factor (FGF-23) (intact und c-terminal), (5) Plasma parathyroid hormone (PTH) (6) Calcium level (7) Plasma Alkaline Phosphatase (8) Plasma soluble Klotho (9) Plasma Hepcidine-25 (10) Serum N-Terminal Propeptide of Type I Collagen (PINP) (11) Pyridinoline (PYD) in the urine (12) Quality of life and (13) Electrophysiological changes, quantified as a. incidence of cardiac arrhythmias in 24 hour ambulatory ECG, b. QT-time in 12-lead ECG and c. QT-dispersion in 12-lead ECG. (14) Echocardiography (15) Monocyte subpopulations | — |
Countries
Germany
Contacts
Public ContactFabio Lizzi
Universität des Saarlandes
Outcome results
None listed