Clinical trial to demonstrate safety and efficacy of an intravenous (i.v.) administration of Feramyl compared to i.v. Ferinject and to iron tablets in patients with iron deficiency anaemia diagnosed before a planned non-cardiac surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 407

Inclusion Criteria

- Males or female; aged = 18 years
- Planned to undergo non-cardiac surgery (e.g., orthopaedic, vascular, visceral surgery) within 28 to 42 days, which requires a fast replenishment of the patients’ iron stores (e.g. if it is not appropriate to postpone surgery) as judged by the treating physician
- Iron deficiency defined as s-ferritin < 100 ng/mL and s-transferrin saturation <20%
- Relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men
- Written informed consent; willing and able to comply with the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 203

Exclusion Criteria

- Pregnancy in female patients or breastfeeding women
- Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
- Severe anaemia with Hb = 8 g/dL
- Any onging bleeding as judged by the treating physician
- Patients receiving blood transfusion 24 weeks prior screening
- Severe physical inability, e.g., ASA physical status IV or V
- Haematuria of unknown or known origin
- Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
- Anticipated medical need for erythropoesis-stimulating agents during the study period
- Patients with any contraindication to the investigational products, e.g.,
-> known sensitivity to iron; HES or anoher ingredient of the investigational products
-> History of systemic allergic reactions
-> Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
-> Acute or chronic intoxication
-> Infection (patient on non-prophylactic antibiotics)
-> Chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range
- Chronic kidney disease, defined as GFR <30 mL/min
- S-Creatinine > 150 µmol/L
- Active uncontrolled immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease
- Primary haematologic disease
- Drug or alcohol abuse according to WHO definition
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
- Current or previous participation in another clinical trial during the last 90 days before screening

Exclusion criteria related to Ferrous sulfate:
- according to SmPC
- hypersensitivity to any ingredient in the formulation
- concomitant parenteral iron
- haemochromatosis, and other iron overload syndromes

Exclusion criteria related to Ferric Carboxymaltose:
- according to SmPC
- hypersensitivity to the active substance, to Ferinject or any of its excipients
- known serious hypersensitivity to other parenteral iron products
- anaemia not attributed to iron deficiency
- evidence of iron overload or disturbances in the utilisation of iron

Exclusion criteria related to Polyglucoferron:
- hypersensitivity to any ingredient in the formulation
- known serious hypersensitivity to other parenteral iron products
- anaemia not attributed to iron deficiency
- evidence of iron overload or disturbances in the utilisation of iron

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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