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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004808-36 | EudraCT Number | ||
| U1111-1176-4563 | Registry Identifier | WHO Universal Trial Number | |
| DRKS00010766 | Registry Identifier | Deutsches Register Klinischer Studien |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Isomaltoside 1000 | Experimental | 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. |
|
| Ferric Carboxymaltose | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside 1000 | Drug |
|
| |
| Ferric Carboxymaltose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of plasma phosphate concentrations. | From baseline to day 35 | |
| Changes of fractional Phosphate urinary excretion. | From baseline to day 35 | |
| Changes of Plasma Vitamin D (active, inactive). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Heine, MD | Universität des Saarlandes | Principal Investigator |
| Danilo Fliser, MD | Universität des Saarlandes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum des Saarlandes | Homburg | Saarland | 66421 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32654663 | Derived | Emrich IE, Lizzi F, Siegel JD, Seiler-Mussler S, Ukena C, Kaddu-Mulindwa D, D'Amelio R, Wagenpfeil S, Brandenburg VM, Bohm M, Fliser D, Heine GH. Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study. BMC Med. 2020 Jul 13;18(1):178. doi: 10.1186/s12916-020-01643-5. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| C522335 | ferric carboxymaltose |
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| Drug |
|
|
| From baseline to day 35 |
| Changes of fibroblast growth factor 23 (intact and c-terminal). | From baseline to day 35 |
| Changes of parathyroid Hormone. | From baseline to day 35 |
| Changes of Plasma calcium. | From baseline to day 35 |
| Changes of Plasma alkaline Phosphatase. | From baseline to day 35 |
| Changes of Plasma soluble Klotho. | From baseline to day 35 |
| Changes of Plasma Hepcidin-25. | From baseline to day 35 |
| Changes of Serum N-Terminal Propeptide of Type I Collagen (PINP). | From baseline to day 35 |
| Changes of Pyridinoline (PYD) in the urine | From baseline to day 35 |
| 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 |
| Incidence of (supra)ventricular cardiac arrhythmias in the ambulatory Electrocardiography. | Before and 7 days after administration of iron compound |
| Changes of QT-time in the 12-lead Electrocardiography. | From baseline to day 35 |
| Changes of QT-Dispersion in the 12-lead Electrocardiography. | From baseline to day 35 |
| Changes of Left Ventricular Mass Index | Echocardiographic measurement | From baseline to day 7 |
| 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. |
| 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. |
| 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 |
| Changes of Left Atrial Volume Index | Echocardiographic measurement | From Baseline to day 7 |
| Changes of Systolic Ejection Fraction | Echocardiographic measurement | From Baseline to day 7 |
| Changes of Diastolic Left Ventricular Function | Echocardiographic measurement | From Baseline to day 7 |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |