Kidney Failure, Chronic
Conditions
Keywords
chronic kidney disease, anemia, intravenous iron, recombinant human erythropoetin
Brief summary
The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.
Detailed description
This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms.
Interventions
DRUGIron sucrose
Sponsors
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent
Exclusion criteria
Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin from baseline to day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events | — |
Countries
Germany
Outcome results
None listed