The purpose of this study is to determine to what extend a treatment with the iron compounds
Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study
the potential clinical impact of hypophosphatemia.
Drug: Iron Isomaltoside 1000
Drug: Ferric Carboxymaltose
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Locations near you
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Full eligibility criteria for NCT02905539
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
- written informed consent,
- 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 ≤
- Intolerance to or inefficacy of an oral iron supplement
- estimated Glomerular Filtration Rate > 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,
- Untreated hyperparathyroidism,
- 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
- Acute febrile infections within the last 7 days,
- Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
- self-reported severe asthma or eczema,
- presence of relative contraindications (any allergy, any immunologic or inflammatory
disease, history of atopic allergies), for which a treatment with the medicinal
investigational products is not deemed indicated by the investigator,
- 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.
All locations for NCT02905539
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421
View full eligibility
Tris trial is registered with FDA with number: NCT02905539. The sponsor of the trial is Saarland University and it is looking for 26 volunteers for the current phase.
Official trial title: A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia
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