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

Conditions: stable patients on hemodialysis with renal anemia
MedDRA version: 9.1Level: LLTClassification code 10019480Term: Hemodialysis
MedDRA version: 9.1Level: LLTClassification code 10058132Term: Renal anemia

Registration Number: EUCTR2006-005916-29-DE

Lead Sponsor: Westpfalz-Klinikum GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

·clinical signs of relevant inflammation or CRP > 30 mg/l
Hemoglobin < 10 g/dl or Hemoglobin >13g/dl
Serum-Ferritin <100 µg/dl or 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Malondialdehyd<br>- DNA-damage (Comet-test)<br>- Glutathion<br>- changes of mitochondrial membran potential<br><br>

Secondary Outcome Measures