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

Anemia, Iron-Deficiency Clinical Trial

— HOMe_aFers_1  

Official title:

A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905539
• Other study ID #: P-0101
• Secondary ID: 2015-004808-36U1
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: June 2020

Study information

• Verified date: April 2019
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• Iron Isomaltoside 1000

• Ferric Carboxymaltose

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Saarland University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypophosphatemia	The incidence of hypophosphatemia is defined as a drop of serum phosphate below 2.0 mg/dl.	From baseline to day 35
Secondary	Changes of plasma phosphate concentrations.		From baseline to day 35
Secondary	Changes of fractional Phosphate urinary excretion.		From baseline to day 35
Secondary	Changes of Plasma Vitamin D (active, inactive).		From baseline to day 35
Secondary	Changes of fibroblast growth factor 23 (intact and c-terminal).		From baseline to day 35
Secondary	Changes of parathyroid Hormone.		From baseline to day 35
Secondary	Changes of Plasma calcium.		From baseline to day 35
Secondary	Changes of Plasma alkaline Phosphatase.		From baseline to day 35
Secondary	Changes of Plasma soluble Klotho.		From baseline to day 35
Secondary	Changes of Plasma Hepcidin-25.		From baseline to day 35
Secondary	Changes of Serum N-Terminal Propeptide of Type I Collagen (PINP).		From baseline to day 35
Secondary	Changes of Pyridinoline (PYD) in the urine		From baseline to day 35
Secondary	Changes of Quality of life.	German Version of the Short Form (36) Health Survey by Matthias Morfeld, Inge Kirchberger, Monika Bullinger.	From baseline to day 35
Secondary	Incidence of (supra)ventricular cardiac arrhythmias in the ambulatory Electrocardiography.		Before and 7 days after administration of iron compound
Secondary	Changes of QT-time in the 12-lead Electrocardiography.		From baseline to day 35
Secondary	Changes of QT-Dispersion in the 12-lead Electrocardiography.		From baseline to day 35
Secondary	Changes of Left Ventricular Mass Index	Echocardiographic measurement	From baseline to day 7
Secondary	Count of monocyte subpopulations.	Count of classical , intermediate and nonclassical monocytes using flow cytometry.	Right before the singular infusion of the iron compound is started and right after infusion of the iron compound is completed.
Secondary	Measurement of phagocytic capacity of monocytes.	Exposition of Monocytes to Fluoresbrite Yellow Green (YG) Carboxylate Microspheres and subsequent flow cytometric count of Fluorescein isothiocyanate-positive Monocytes.	Right before the singular infusion of the iron compound is started and right after the infusion of iron compound is completed.
Secondary	Changes of fatigue	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.)	From baseline to day 35
Secondary	Changes of Left Atrial Volume Index	Echocardiographic measurement	From Baseline to day 7
Secondary	Changes of Systolic Ejection Fraction	Echocardiographic measurement	From Baseline to day 7
Secondary	Changes of Diastolic Left Ventricular Function	Echocardiographic measurement	From Baseline to day 7