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

NCT04087993 | Withdrawn Phase 3 DMC

• 1 other identifier: TMP0916_02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Keywords

pre surgery iron treatment

Outcome Measures

Primary Outcomes (2)

• 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

  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

  approx. 8 hours

Secondary Outcomes (38)

• Units of allogenic red blood cell transfusion

  baseline to visit 5 approx. 70 day

• Hb values

  baseline to visit 4 approx. 35 day

• Hb values

  baseline to visit 5 approx. 70 day

• Transferrin Saturation (TSAT) values

  baseline to visit 5 approx. 70 day

• Transferrin Saturation (TSAT) values

  baseline to visit 4 approx. 35 day

Study Arms (3)

Polyglucoferron

EXPERIMENTAL

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

Drug: Polyglucoferron

Ferric Carboxymaltose

ACTIVE COMPARATOR

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

Drug: Ferric carboxymaltose

Ferrous sulfate

ACTIVE COMPARATOR

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

Drug: Ferrous Sulfate

Interventions

Polyglucoferron DRUG

intravenous administration

Also known as: Feramyl

Polyglucoferron

Ferric carboxymaltose DRUG

intravenous administration

Also known as: Ferinject

Ferric Carboxymaltose

Ferrous Sulfate DRUG

oral administration

Also known as: Ferro sanol duodenal

Ferrous sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.,
• known sensitivity to iron or an ingredient of the investigational products
• History of systemic allergic reactions
• Haemachromatosis, thalassemia or TSAT \>50% as indicator of iron overload
• Acute or chronic intoxication
• Infection (patient on non-prophylactic antibiotics)

Sponsors & Collaborators

• Dr. Frank Behrens: lead
• University Hospital Frankfurt, Department of Anaesthesiology: collaborator
• IRON4U: collaborator
• University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling: collaborator

Study Sites (1)

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

Frankfurt, Hessia, 60590, Germany

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kai Zacharowski, Prof. MD

  University Hospital of Goethe-University Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor representative

Model Details: 2:2:1 distribution Polyglucoferron, Ferric Carboxymaltose i.v., or oral iron substitution with Ferrous sulfate. After safety assessment of first 35 patients treated with Polyglucoferron or Ferric Carboxymaltose i.v. respectively, Ferric Carboxymaltose arm will be closed.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 12, 2019
• Study Start: May 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

DE (1)