Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients

Randomised, Open Lable, Active Controlled Clinical Trial to Demonstrate Safety and Efficacy of an i.v. Administration of Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients With Elective Non-cardiac Surgery (IDA I)

Patients with IDA and for whom fast replenishment of iron stores is necessary, e.g. if its not appropriated to postpone surgery, will be identified within 28 to 42 days before surgery. Patients will be randomised to receive either Polyglucoferron intravenously (i.v.), Ferric Carboxymaltose i.v. or oral iron substitution with Ferrous sulfate.

Randomised, active-controlled, open-labelled, parallel group, multicentre study to demonstrate superiority of Polyglucoferron i.v. compared to oral iron substitution for the treatment of iron deficient anaemic patients who need fast replenishment of iron stores as judged by the treating physician, e.g. if it is not appropriate to postpone surgery, before elective non-cardiac surgery and superiority of Polyglucoferron i.v. vs Ferric Carboxymaltose in short term safety monitoring.

Inclusion Criteria:

• Male 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

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 ingoing bleeding as judged by the treating physician

• Patients receiving blood transfusion 24 weeks prior screening

• Severe physical inability, e.g., American Society of Anesthesiologists (ASA) physical status IV or V

• Haematuria and proteinuria 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 erythropoiesis-stimulating agents during the study period

• Patients with any contraindication to the investigational products, e.g.,

  1. known sensitivity to iron or an ingredient of the investigational products
  2. History of systemic allergic reactions
  3. Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
  4. Acute or chronic intoxication
  5. Infection (patient on non-prophylactic antibiotics)
  6. Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range

• Chronic kidney disease, defined as Glomerular Filtration Rate (GFR) <30 mL/min

• Serum 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

  1. according to summary of product characteristics (SmPC)
  2. hypersensitivity to any ingredient in the formulation
  3. concomitant parenteral iron
  4. haemochromatosis, and other iron overload syndromes

• Exclusion criteria related to Ferric Carboxymaltose:

  1. according to SmPC
  2. hypersensitivity to the active substance, to Ferinject or any of its excipients
  3. known serious hypersensitivity to other parenteral iron products
  4. anaemia not attributed to iron deficiency
  5. evidence of iron overload or disturbances in the utilisation of iron

• Exclusion criteria related to Polyglucoferron f) hypersensitivity to any ingredient in the formulation

  1. known serious hypersensitivity to other parenteral iron products
  2. anaemia not attributed to iron deficiency
  3. evidence of iron overload or disturbances in the utilisation of iron