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Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients (IDA-I)

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ClinicalTrials.gov Identifier: NCT04087993
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
University Hospital Frankfurt, Department of Anaesthesiology
IRON4U
University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling
Information provided by (Responsible Party):
Dr. Frank Behrens, Fraunhofer Institute for Molecular Biology and Applied Ecology

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Polyglucoferron Drug: Ferric carboxymaltose Drug: Ferrous Sulfate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised, Open Lable, Active Controlled Clinical Trial to Demonstrate Safety and Efficacy of an i.v. Administration of Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients With Elective Non-cardiac Surgery (IDA I)
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Polyglucoferron
once intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg
Drug: Polyglucoferron
intravenous administration
Other Name: Feramyl

Active Comparator: 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)
Drug: Ferric carboxymaltose
intravenous administration
Other Name: Ferinject

Active Comparator: 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
Drug: Ferrous Sulfate
oral administration
Other Name: Ferro sanol duodenal




Primary Outcome Measures :
  1. Normalisation or Increase of hemaglobin(Hb)-level [ Time Frame: baseline (BL) to day before surgery (visit 4) ]
    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

  2. Detection of urine iron [ Time Frame: approx. 8 hours ]
    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


Secondary Outcome Measures :
  1. Units of allogenic red blood cell transfusion [ Time Frame: baseline to visit 5 approx. 70 day ]
    Proportion of units of allogenic red blood cell transfusion from BL until visit 5

  2. Hb values [ Time Frame: baseline to visit 4 approx. 35 day ]
    Mean change in Hb at visit 4 compared to BL

  3. Hb values [ Time Frame: baseline to visit 5 approx. 70 day ]
    Mean change in Hb at visit 5 compared to BL

  4. Transferrin Saturation (TSAT) values [ Time Frame: baseline to visit 5 approx. 70 day ]
    Mean change in TSAT at visit 5 compared to BL

  5. Transferrin Saturation (TSAT) values [ Time Frame: baseline to visit 4 approx. 35 day ]
    Mean change in TSAT at visit 4 compared to BL

  6. iron values [ Time Frame: baseline to visit 4 approx. 35 day ]
    Mean change in serum iron at visit 4 compared to BL

  7. iron values [ Time Frame: baseline to visit 5 approx. 70 day ]
    Mean change in serum iron at visit 5 compared to BL

  8. ferritin values [ Time Frame: baseline to visit 5 approx. 70 day ]
    Mean change in serum ferritin at visit 5 compared to BL

  9. ferritin values [ Time Frame: baseline to visit 4 approx. 35 day ]
    Mean change in serum ferritin at visit 4 compared to BL

  10. transferrin values [ Time Frame: baseline to visit 4 approx. 35 day ]
    Mean change in serum ferritin at visit 4 compared to BL

  11. transferrin values [ Time Frame: baseline to visit 5 approx. 70 day ]
    Mean change in serum ferritin at visit 5 compared to BL

  12. number of adverse events (AE)/serious adverse events (SAE) [ Time Frame: baseline to 28 days after surgery, approx. 56 days ]
    Tolerability measured by overall number of AEs/SAEs until 28 days after surgery

  13. incidence of adverse events (AE)/serious adverse events (SAE) [ Time Frame: baseline to 28 days after surgery, approx. 56 days ]
    Tolerability by incidence of AEs/SAEs until 28 days after surgery

  14. Seriousness of adverse events (AE)/serious adverse events (SAE) [ Time Frame: baseline to 28 days after surgery, approx. 56 days ]
    Overall tolerability by seriousness of AEs/SAEs until 28 days after surgery

  15. Relationship of adverse events (AE)/serious adverse events (SAE) [ Time Frame: baseline to 28 days after surgery, approx. 56 days ]
    Overall tolerability by relationship of AEs/SAEs until 28 days after surgery

  16. Severity of adverse events (AE)/serious adverse events (SAE) [ Time Frame: baseline to 28 days after surgery, approx. 56 days ]
    Overall tolerability by severity of AEs/SAEs until 28 days after surgery

  17. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes White blood count on each visit

  18. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes in thrombocytes on each visit

  19. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes in serum creatinine on each visit

  20. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes in AST on each visit

  21. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes in ALT on each visit

  22. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes in gamma GT on each visit

  23. Changes in Laboratory parameters [ Time Frame: throughout study conduction, max 77 days ]
    Changes in phosphate on each visit

  24. Changes in vital signs [ Time Frame: throughout study conduction, max 77 days ]
    Changes in vital signs on each visit

  25. Changes in blood pressure [ Time Frame: throughout study conduction, max 77 days ]
    Changes in blood pressure on each visit

  26. Changes in heart rate [ Time Frame: throughout study conduction, max 77 days ]
    Changes in heart rate on each visit

  27. Changes in physical exam [ Time Frame: throughout study conduction, max 77 days ]
    Changes in physical exam on each visit

  28. adverse events related to administration [ Time Frame: at baseline ]
    AEs related to injection/infusion site reactions (i.v. group only)

  29. adverse events related to administration [ Time Frame: 7 days after baseline, at Visit 3 ]
    AEs related to injection/infusion site reactions (i.v. group only)

  30. hypersensitivity reactions [ Time Frame: at baseline ]
    documentation of anaphylatic or anaphylactoid reactions (i.v. group only)

  31. hypersensitivity reactions [ Time Frame: at study visit 3 ]
    documentation of anaphylatic or anaphylactoid reactions (i.v. group only)

  32. Mortality [ Time Frame: within 28 days after surgery, approx. 56 days ]
    All-cause mortality within 28 days after surgery

  33. Quality of Life (SF36) [ Time Frame: base line to visit 4 approx 35 days ]
    Assessment of Quality of Life by SF36 questionnaire at visits 4 compared to BL

  34. Quality of Life (SF36) [ Time Frame: baseline to visit 5 approx 70 days ]
    Assessment of Quality of Life by SF36 questionnaire at visits 5 compared to BL

  35. Duration of hospital stay [ Time Frame: 28 days ]
    Duration of hospital stay (days) until 28 days after surgery

  36. Number of patients with normalized Hb-values [ Time Frame: baseline to visit 4 approx 35 days ]
    Number of patients with normalized Hb-values after iron substitution (n, %) at visits 4 and 5

  37. Number of patients with normalized Hb-values [ Time Frame: baseline to visit 5 approx 70 days ]
    Number of patients with normalized Hb-values after iron substitution (n, %) at and 5

  38. Analysis of total iron levels [ Time Frame: approx 4 hours ]
    Analysis of total iron levels in plasma at BL after end of iron administration (for the i.v. groups (safety analysis group) only)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087993


Contacts
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Contact: Tanja Rossmanith, PhD 0049696301 ext 80208 tanja.rossmanith@ime.fraunhofer.de
Contact: Gemma Bruno

Locations
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Germany
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Goethe-University Recruiting
Frankfurt, Hessia, Germany, 60590
Contact: Patrick Meybohm, MD         
Contact: Kai Zacharowski, MD         
Sponsors and Collaborators
Dr. Frank Behrens
University Hospital Frankfurt, Department of Anaesthesiology
IRON4U
University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling
Investigators
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Principal Investigator: Kai Zacharowski, Prof. MD University Hospital of Goethe-University Frankfurt

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Responsible Party: Dr. Frank Behrens, Sponsor representative, Fraunhofer Institute for Molecular Biology and Applied Ecology
ClinicalTrials.gov Identifier: NCT04087993     History of Changes
Other Study ID Numbers: TMP0916_02
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Frank Behrens, Fraunhofer Institute for Molecular Biology and Applied Ecology:
pre surgery iron treatment
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Ferric Compounds
Hematinics