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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Saarland University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes of plasma phosphate concentrations. [ Time Frame: From baseline to day 35 ]
  • Changes of fractional Phosphate urinary excretion. [ Time Frame: From baseline to day 35 ]
  • Changes of Plasma Vitamin D (active, inactive). [ Time Frame: From baseline to day 35 ]
  • Changes of fibroblast growth factor 23 (intact and c-terminal). [ Time Frame: From baseline to day 35 ]
  • Changes of parathyroid Hormone. [ Time Frame: From baseline to day 35 ]
  • Changes of Plasma calcium. [ Time Frame: From baseline to day 35 ]
  • Changes of Plasma alkaline Phosphatase. [ Time Frame: From baseline to day 35 ]
  • Changes of Plasma soluble Klotho. [ Time Frame: From baseline to day 35 ]
  • Changes of Plasma Hepcidin-25. [ Time Frame: From baseline to day 35 ]
  • Changes of Serum N-Terminal Propeptide of Type I Collagen (PINP). [ Time Frame: From baseline to day 35 ]
  • Changes of Pyridinoline (PYD) in the urine [ Time Frame: From baseline to day 35 ]
  • 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.
  • Incidence of (supra)ventricular cardiac arrhythmias in the ambulatory Electrocardiography. [ Time Frame: Before and 7 days after administration of iron compound ]
  • Changes of QT-time in the 12-lead Electrocardiography. [ Time Frame: From baseline to day 35 ]
  • Changes of QT-Dispersion in the 12-lead Electrocardiography. [ Time Frame: From baseline to day 35 ]
  • Changes of Left Ventricular Mass Index [ Time Frame: From baseline to day 7 ]
    Echocardiographic measurement
  • 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.
  • 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.
  • 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.)
  • Changes of Left Atrial Volume Index [ Time Frame: From Baseline to day 7 ]
    Echocardiographic measurement
  • Changes of Systolic Ejection Fraction [ Time Frame: From Baseline to day 7 ]
    Echocardiographic measurement
  • Changes of Diastolic Left Ventricular Function [ Time Frame: From Baseline to day 7 ]
    Echocardiographic measurement


Original Secondary Outcome: Same as current

Information By: Saarland University

Dates:
Date Received: September 8, 2016
Date Started: July 2016
Date Completion: June 2018
Last Updated: September 13, 2016
Last Verified: September 2016