DRKS00010766
Completed
Phase 4
A randomized, double-blind comparative study comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for iron substitution in iron-deficiency anemia - HOMe aFers 1
niversität des Saarlandes0 sites26 target enrollmentJune 27, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- MedDRA - 10002062 (Anaemia iron deficiency)
- Sponsor
- niversität des Saarlandes
- Enrollment
- 26
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 \= 30 %,
- •Intolerance to or inefficacy of an oral iron supplement
- •eGFR \> 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 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,
Outcomes
Primary Outcomes
Not specified
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