Status:
COMPLETED
Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients
Lead Sponsor:
Medical University of Vienna
Conditions:
Anemia of Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without addi...
Eligibility Criteria
Inclusion
- Signed informed consent
- Male and female patients aged ≥ 18
- Patients with anemia and end stage kidney disease on dialysis
- Hemoglobin ≥ 8,5g/dl
- Ferritin \< 1000mg/dl
- TSAT \< 50%
- CRP \< 5mg/dl
Exclusion
- Hemoglobin \< 8,5g/dl
- Pregnancy or Nursing
- Known allergic reaction to i.v. iron supplementation or to ingredients of Investigational Medicinal Product (IMP)
- Chronic infections (HIV, Hep B, Hep C)
- Acute infections (CRP\>5mg/dl; Antibiotic therapy except for prophylactic use)
- Malignant tumor disease
- Oral iron supplementation at study inclusion
- Participation in a different study at the same time
- Active bleeding issues
- Surgical intervention within the last 4 weeks before study inclusion
- Mental diseases
- Bronchial asthma
- Atopic allergy
- Eczema
- Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study inclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02198495
Start Date
September 1 2014
End Date
May 1 2019
Last Update
September 11 2020
Active Locations (2)
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1
Medical University of Vienna, Division of Nephrology and Dialysis
Vienna, Austria, 1090
2
Wiener Dialysezentrum GmbH
Vienna, Austria, 1220