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A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer (HOMe_aFers_1)

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ClinicalTrials.gov Identifier: NCT02905539
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Saarland University

Brief Summary:
The purpose of this study is to determine to what extend a treatment with the iron compounds Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study the potential clinical impact of hypophosphatemia.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Drug: Iron Isomaltoside 1000 Drug: Ferric Carboxymaltose Phase 4

Detailed Description:

Recent studies suggested that intravenous iron preparations for anemia treatment may have adverse effects on phosphorus regulation, as they may induce an increase in the phosphaturic hormone Fibroblast Growth Factor-23 (FGF-23) and a subsequent fall in plasma phosphorus levels.

So far it is unknown if these effects are class- or substance-specific.

This study will address the question whether among female participants with iron deficiency anemia the application of ferric-(III)-derisomaltose and ferric carboxymaltose will cause episodes of hypophosphatemia to same extend. The investigators will additionally compare the effects of the two iron preparations on other parameters of calcium-phosphate metabolism, and decipher potential consequences of hypophosphatemia by analysing cardiac function, immunological parameters and quality of life.

In order to investigate these outcomes, 60 women with iron deficient anemia will be randomised to receive either ferric-(III)-derisomaltose or ferric carboxymaltose.

The monocentric study will be conducted at Saarland University Medical Center. For each participating woman, the study comprises five visits to the study center during a period of five weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Iron Isomaltoside 1000
Subjects receive Iron Isomaltoside 1000 solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg.
Drug: Iron Isomaltoside 1000
Other Name: Monofer

Active Comparator: Ferric Carboxymaltose
Subjects receive Ferric Carboxymaltose solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg.
Drug: Ferric Carboxymaltose
Other Name: Ferinject




Primary Outcome Measures :
  1. Incidence of hypophosphatemia [ Time Frame: From baseline to day 35 ]
    The incidence of hypophosphatemia is defined as a drop of serum phosphate below 2.0 mg/dl.


Secondary Outcome Measures :
  1. Changes of plasma phosphate concentrations. [ Time Frame: From baseline to day 35 ]
  2. Changes of fractional Phosphate urinary excretion. [ Time Frame: From baseline to day 35 ]
  3. Changes of Plasma Vitamin D (active, inactive). [ Time Frame: From baseline to day 35 ]
  4. Changes of fibroblast growth factor 23 (intact and c-terminal). [ Time Frame: From baseline to day 35 ]
  5. Changes of parathyroid Hormone. [ Time Frame: From baseline to day 35 ]
  6. Changes of Plasma calcium. [ Time Frame: From baseline to day 35 ]
  7. Changes of Plasma alkaline Phosphatase. [ Time Frame: From baseline to day 35 ]
  8. Changes of Plasma soluble Klotho. [ Time Frame: From baseline to day 35 ]
  9. Changes of Plasma Hepcidin-25. [ Time Frame: From baseline to day 35 ]
  10. Changes of Serum N-Terminal Propeptide of Type I Collagen (PINP). [ Time Frame: From baseline to day 35 ]
  11. Changes of Pyridinoline (PYD) in the urine [ Time Frame: From baseline to day 35 ]
  12. Changes of Quality of life. [ Time Frame: From baseline to day 35 ]
    German Version of the Short Form (36) Health Survey by Matthias Morfeld, Inge Kirchberger, Monika Bullinger.

  13. Incidence of (supra)ventricular cardiac arrhythmias in the ambulatory Electrocardiography. [ Time Frame: Before and 7 days after administration of iron compound ]
  14. Changes of QT-time in the 12-lead Electrocardiography. [ Time Frame: From baseline to day 35 ]
  15. Changes of QT-Dispersion in the 12-lead Electrocardiography. [ Time Frame: From baseline to day 35 ]
  16. Changes of Left Ventricular Mass Index [ Time Frame: From baseline to day 7 ]
    Echocardiographic measurement

  17. Count of monocyte subpopulations. [ Time Frame: Right before the singular infusion of the iron compound is started and right after infusion of the iron compound is completed. ]
    Count of classical , intermediate and nonclassical monocytes using flow cytometry.

  18. Measurement of phagocytic capacity of monocytes. [ Time Frame: Right before the singular infusion of the iron compound is started and right after the infusion of iron compound is completed. ]
    Exposition of Monocytes to Fluoresbrite Yellow Green (YG) Carboxylate Microspheres and subsequent flow cytometric count of Fluorescein isothiocyanate-positive Monocytes.

  19. Changes of fatigue [ Time Frame: From baseline to day 35 ]
    The German Version of the Multidimensional Fatigue Inventory. (Smets E. M. A., Garssen B., Bonke B. and Haes de J. C. J. M. (1995). The Multidimensional Fatigue Inventory (MFI); Psychometric qualities of an instrument to assess fatigue. Journal of Psychosomatic Research, 39, 315-325.)

  20. Changes of Left Atrial Volume Index [ Time Frame: From Baseline to day 7 ]
    Echocardiographic measurement

  21. Changes of Systolic Ejection Fraction [ Time Frame: From Baseline to day 7 ]
    Echocardiographic measurement

  22. Changes of Diastolic Left Ventricular Function [ Time Frame: From Baseline to day 7 ]
    Echocardiographic measurement



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

Inclusion Criteria:

  • written informed consent,
  • female,
  • gynecological blood losses,
  • age ≥ 18 years,
  • iron deficiency anemia,
  • Hemoglobin < 12,0 g/dl,
  • Serum-Ferritin ≤ 100 ng/ml or Serum-Ferritin ≤ 300 ng/ml and Transferrin-saturation ≤ 30 %,
  • Intolerance to or inefficacy of an oral iron supplement
  • estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²

Exclusion Criteria:

  • known hypersensitivity to MonoFer® or FERINJECT®,
  • severe, known hypersensitivity to other intravenous iron preparations,
  • Plasma Phosphate < 2.5 mg/dl at screening,
  • Hemochromatosis,
  • Untreated hyperparathyroidism,
  • Renal replacement therapy/kidney transplantation,
  • Active malignant disease, disease-free survival for less than 5 years,
  • Intravenous iron administration within the last 30 days,
  • Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
  • Surgery under anesthetic within the last 10 days,
  • Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
  • Acute febrile infections within the last 7 days,
  • Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
  • self-reported severe asthma or eczema,
  • presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
  • pregnancy,
  • women of childbearing potential without an effective method of contraception,
  • lactating women,
  • Present alcohol or drug dependency,
  • Patients with a history of a psychological illness or seizures,
  • Non-compliance or administration of any investigational drug within 30 days preceding the study start.

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): NCT02905539


Locations
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Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
Saarland University
Investigators
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Principal Investigator: Gunnar Heine, MD Saarland University
Study Director: Danilo Fliser, MD Saarland University

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Responsible Party: Saarland University
ClinicalTrials.gov Identifier: NCT02905539     History of Changes
Other Study ID Numbers: P-0101
2015-004808-36 ( EudraCT Number )
U1111-1176-4563 ( Registry Identifier: WHO Universal Trial Number )
DRKS00010766 ( Registry Identifier: Deutsches Register Klinischer Studien )
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Saarland University:
Iron
anemia
phosphorus
FGF-23
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Iron isomaltoside 1000
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics