IFEROS – Influence of intravenous iron therapeutics on oxidative stress in hemodialysis patients

INTERVENTION: Trade Name: CosmoFer Pharmaceutical Form: Injection* CAS Number: 9004664 Other descriptive name: IRON DEXTRAN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 50‐ Trade Name: Ferrlecit Pharmaceutical Form: Injection* CAS Number: 8500011872 Other descriptive name: SODIUM‐IRON‐GLUCONATE COMPLEX Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 62,5/5‐ Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 62,5/5‐ Trade Name: Venofer Pharmaceutical Form: Injection* CAS Number: 8047674 Other descriptive name: IRON SUCROSE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100/5‐ Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 100/5‐ CONDITION: stable patients on hemodialysis with renal anemia ; MedDRA version: 9.1 Level: LLT Classification code 10019480 Term: Hemodialysis ; MedDRA version: 9.1 Level: LLT Classification code 10058132 Term: Renal anemia PRIMARY OUTCOME: Main Objective: investigate the influence of different iro preparations on oxidative stress and apoptotic changes of peripheral blood leukocytes in hemodialysis patients Primary end point(s): measurement of oxidative stress and apoptotic changes in peripheral blood leukocytes:; ‐ Malondialdehyd; ‐ DNA‐damage (Comet‐test); ‐ Glutathion; ‐ changes of mitochondrial membran potential; ; Secondary Objective: none INCLUSION CRITERIA: stable hemodialysis patients at least three months on HD age > 18 years adequate hemodialysis with kt/v > 1,3 adequate iron stores with Serum‐Ferritin >100 µg/dl and TSAT >20% or hypochrome erythrocytes < 10% CRP < 30 mg/l Hemoglobin >10 g/dl stable on erythropoeitin: erythropoetin‐dose 50 – 150 IU/kg/Woche and no change of erythropoeitin‐dose > 30% in the last 8 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range