Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency

NCT03817957 | Completed Phase 3 DMC

• 1 other identifier: TMP0916_03
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron

Conditions

Iron Deficiency Anemia

Keywords

post surgery anemia treatment,

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl

  Proportion of patients in the Polyglucoferron i.v. arm compared to oral iron substitution with Ferrous sulfate at visit 4 compared to Baseline (BL)

  Baseline to approximately 30 days post-baseline (visit 4)

• pre post difference of volumen-corrected urine iron levels

  Pre-post difference of volume-corrected urine iron levels measured before and 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, compared between Polyglucoferron and Ferric Carboxymaltose (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine).

  urine sampled prior to administration and approximately 1 to 8 hours post-baseline

Secondary Outcomes (40)

• Proportion of patients with normalization of Hemoglobin (Hb) at visit 4

  30 days after baseline (Visit 4)

• Level of Hb until visit 4

  Baseline to 30 days after baseline (visit 4)

• Level of Transferrin Saturation (TSAT) until visit 4

  Baseline to 30 days after baseline (visit 4)

• Level of serum-iron until visit 4

  Baseline to 30 days after baseline (visit 4)

• Level of serum-transferrin until visit 4

  Baseline to 30 days after baseline (visit 4)

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:

• Males or female; aged ≥ 18 years
• Patients after major surgery (e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) with risk of Hb reduction and/or blood loss who develop anaemia defined as haemoglobin of \<12 g/dL for female and \<13 g/dL for men within 12 to 72 h after start of surgery and with confirmation at Baseline
• Confirmed and documented preoperative iron deficiency defined as S-ferritin \<100 ng/mL without anaemia (Hb ≥12 g/dL for female and ≥13 g/dL for male) within 28 days before surgery
• need for fast iron replenishment as judged by the treating physician
• Written informed consent; willing/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 physical inability, e.g., American society of anesthesiologists (ASA) physical status IV or V
• Patients receiving blood transfusion 24 week prior surgery
• 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 main study period
• Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed determined 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.,
• known sensitivity to iron or an ingredient of the investigational products
• Significant 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)
• 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

Sponsors & Collaborators

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

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

• Patrick Meybohm, 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. Remaining patients will be distributed in an 2:1 mode to Polyglucoferron or oral iron

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: January 28, 2019
• Study Start: September 18, 2018
• Primary Completion: December 4, 2023
• Study Completion: October 21, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)