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

NCT ID: NCT04087993

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polyglucoferron

once intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg

Group Type: EXPERIMENTAL

Polyglucoferron

Intervention Type: DRUG

intravenous administration

Ferric Carboxymaltose

Once intravenously (a second administration is allowed), dosing according to Hb-levels and body weight (500 - 2000 mg, max. single dose of 1000 mg)

Group Type: ACTIVE_COMPARATOR

Ferric carboxymaltose

Intervention Type: DRUG

intravenous administration

Ferrous sulfate

capsules, orally, dosing 50 mg - 200 mg (50 mg: 1 capsule in total, 200 mg: 4 capsules in total, taken as 2 capsules twice daily), duration of treatment 28 days

Group Type: ACTIVE_COMPARATOR

Ferrous Sulfate

Intervention Type: DRUG

oral administration

Interventions

Polyglucoferron

intravenous administration

Intervention Type: DRUG

Ferric carboxymaltose

intravenous administration

Intervention Type: DRUG

Ferrous Sulfate

oral administration

Intervention Type: DRUG

Other Intervention Names

Feramyl; Ferinject; Ferro sanol duodenal

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Frankfurt, Department of Anaesthesiology

UNKNOWN

Sponsor Role: collaborator

IRON4U

UNKNOWN

Sponsor Role: collaborator

University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling

UNKNOWN

Sponsor Role: collaborator

Dr. Frank Behrens

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frank Behrens

Sponsor representative

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kai Zacharowski, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Goethe-University Frankfurt

Locations

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

Frankfurt, Hessia, Germany

Countries

Germany

Other Identifiers

TMP0916_02

Identifier Type: -

Identifier Source: org_study_id