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

1.Male or female; aged = 18 years
2.Planned to undergo elective 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
3.Iron deficiency defined as s-ferritin <100 ng/mL and s-transferrin saturation <20%
4.Relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men
5.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

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

18.Exclusion criteria related to Ferrous sulfate
a)according to SmPC
b)hypersensitivity to any ingredient in the formulation
c)concomitant parenteral iron
d)haemochromatosis, and other iron overload syndromes

19.Exclusion criteria related to Ferric Carboxymaltose:
a)according to SmPC
b)hypersensitivity to the active substance, to Ferinject or any of its excipients
c)known serious hypersensitivity to other parenteral iron products
d)anaemia not attributed to iron deficiency
e)evidence of iron overload or disturbances in the utilisation of iron

20.Exclusion criteria related to Polyglucoferron
a)hypersensitivity to any ingredient in the formulation
b)known serious hypersensitivity to other parenteral iron products
c)anaemia not attributed to iron deficiency
d)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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