A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saarland University; Universität des Saarlandes
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

• 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

• estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²

Exclusion Criteria:

• known hypersensitivity to MonoFer® or FERINJECT®,

• severe, known hypersensitivity to other intravenous iron preparations,

• Plasma Phosphate < 2.5 mg/dl at screening,

• Hemochromatosis,

• 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 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 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,

• 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.