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

Dr. Frank Behrens

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Iron Deficiency Anemia

Interventions

PolyglucoferronDRUG

intravenous administration

Ferric carboxymaltoseDRUG

intravenous administration

Ferrous SulfateDRUG

oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Goethe-University

Frankfurt, Hessia, Germany

Outcomes

Primary Outcomes

Normalisation or Increase of hemaglobin(Hb)-level

Proportion of patients achieving normalized Hb-levels (according to World Health Organization (WHO) definition) or an increase of at least 1.5 g/dl Hb at day before surgery (visit 4) compared to baseline (BL) in the Polyglucoferron treatment arm compared to oral iron substitution with Ferrous sulfate

Time frame: baseline (BL) to day before surgery (visit 4)

Detection of urine iron

Detection of urine iron in the first urine after the end of i.v. administration, defined as short term safety surrogate marker after administration of the i.v. treatments

Time frame: approx. 8 hours

Secondary Outcomes

Units of allogenic red blood cell transfusion

Proportion of units of allogenic red blood cell transfusion from BL until visit 5

Time frame: baseline to visit 5 approx. 70 day

Hb values

Mean change in Hb at visit 4 compared to BL

Time frame: baseline to visit 4 approx. 35 day

Hb values

Mean change in Hb at visit 5 compared to BL

Time frame: baseline to visit 5 approx. 70 day

Transferrin Saturation (TSAT) values

Mean change in TSAT at visit 5 compared to BL

Time frame: baseline to visit 5 approx. 70 day

Transferrin Saturation (TSAT) values

Mean change in TSAT at visit 4 compared to BL

Time frame: baseline to visit 4 approx. 35 day

Data from ClinicalTrials.gov

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iron values

Mean change in serum iron at visit 4 compared to BL

Time frame: baseline to visit 4 approx. 35 day

iron values

Mean change in serum iron at visit 5 compared to BL

Time frame: baseline to visit 5 approx. 70 day

ferritin values

Mean change in serum ferritin at visit 5 compared to BL

Time frame: baseline to visit 5 approx. 70 day

ferritin values

Mean change in serum ferritin at visit 4 compared to BL

Time frame: baseline to visit 4 approx. 35 day

transferrin values

Mean change in serum ferritin at visit 4 compared to BL

Time frame: baseline to visit 4 approx. 35 day

transferrin values

Mean change in serum ferritin at visit 5 compared to BL

Time frame: baseline to visit 5 approx. 70 day

number of adverse events (AE)/serious adverse events (SAE)

Tolerability measured by overall number of AEs/SAEs until 28 days after surgery

Time frame: baseline to 28 days after surgery, approx. 56 days

incidence of adverse events (AE)/serious adverse events (SAE)

Tolerability by incidence of AEs/SAEs until 28 days after surgery

Time frame: baseline to 28 days after surgery, approx. 56 days

Seriousness of adverse events (AE)/serious adverse events (SAE)

Overall tolerability by seriousness of AEs/SAEs until 28 days after surgery

Time frame: baseline to 28 days after surgery, approx. 56 days

Relationship of adverse events (AE)/serious adverse events (SAE)

Overall tolerability by relationship of AEs/SAEs until 28 days after surgery

Time frame: baseline to 28 days after surgery, approx. 56 days

Severity of adverse events (AE)/serious adverse events (SAE)

Overall tolerability by severity of AEs/SAEs until 28 days after surgery

Time frame: baseline to 28 days after surgery, approx. 56 days

Changes in Laboratory parameters

Changes White blood count on each visit