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
Conditions
Interventions
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
Sponsors
Westpfalz-Klinikum GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: ·clinical signs of relevant inflammation or CRP > 30 mg/l Hemoglobin 13g/dl Serum-Ferritin 800 µg/dl TSAT > 50% weekly iron substitition > 100 mg hematologic systemic disease immunsuppressive or cytostatic therapy therapy with vitamin C, vitamin E or Acetylcystein pregnany
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: investigate the influence of different iro preparations on oxidative stress and apoptotic changes of peripheral blood leukocytes in hemodialysis patients;Secondary Objective: none;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 | — |
Countries
Germany
Outcome results
None listed