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 diganosis before a planned operation who develop anaemia before, during or after surgery

Phase 1

• Conditions: pre-operative iron deficiency in patients with planned elective surgery and pre-/post-operative iron deficiency; MedDRA version: 20.0Level: LLTClassification code 10022974Term: Iron deficiency anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-003439-12-AT
• Lead Sponsor: Fraunhofer Gesellschaft für sein Institut für Translationale Medizin und Pharmakologie (ITMP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-25
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• Male or female; aged = 18 years
• Patients with planned surgery (e.g., orthopaedic/trauma, vascular,
visceral, cardiac surgery)
• Confirmed and documented preoperative (within 28 days before
surgery) iron deficiency defined as S-ferritin <100 ng/mL
• Confirmed and documented anaemia (Hb <12 g/dL for female and
<13 g/dL for male) up to 10 days before surgery or until 72 h after
start of surgery
• Confirmed anaemia at Baseline (Hb <12 g/dL for female and <13 g/dL
for male)
• Written informed consent; willing / 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 physical inability, e.g., ASA physical status IV or V
• Patients receiving blood transfusion 24 week prior surgery
• Patients with severe anaemia defined as Hb = 8 g/dL or with moderate
anaemia with evidence of risk factors or signs of cardiac or cerebral
ischaemia defined as clinical need for allogenic red blood cell
transfusion (see section 4.4)
• 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 main study period
• Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage, whichever occurs earlier in routine care
• Patients with any contraindication to the investigational products, e.g.,
o known sensitivity to iron or an ingredient of the investigational products
o Significant history of systemic allergic reactions
o Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
o Acute or chronic intoxication
o Infection (patient on non-prophylactic antibiotics)
o 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
• Immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease if active and uncontrolled
• 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 Ferric Carboxymaltose 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