Continuos versus periodic intravenous iron supplementation in maintenance hemodialysis patients

Phase 1

• Conditions: Anemia and iron deficiency in patients with end-stage renal disease on maintenance dialysis; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-003914-15-AT
• Lead Sponsor: Medizinische Universität Wien, Klinik für Innere Medizin III, Klin. Abteilung für Nephrologie und Dialyse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-27
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

• Patients with anemia and end-stage renal disease on maintenance hemodialysis
• Hemoglobin = 8,5 g/dl
• Ferritin < 1000 mg/dl
• TSAT < 50%
• CRP < 5 mg/dl
• Age> 18 years
• Written informed consent
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

• Hemoglobin < 8,5 g/dl
• Pregnancy and nursing period
• Prior allergic reaction on intravenous iron therapy or known allergy on ingredients of the IMP
• Chronic infectious disease (HIV, Hep B, Hep C)
• Malignant tumor disease
• Active infection (CRP > 5 mg/dl, antibiotic treatment – except prophylactic antibiotic treatment)
• Patients on oral iron therapy at study inclusion
• Simultaneous participation in another clinical trial
• Active bleeding
• Surgical treatment within four weeks prior study inclusion
• Mental disorder
• Blood transfusion within four weeks prior study inclusion
• Drug or alcohol abuse
• Asthma bronchiale
• Atopic disease
• Eczema

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified