Intravenous Iron in Patients With Anemia of Chronic Kidney Disease
This trial is active, not recruiting.
|Condition||kidney failure, chronic|
|Sponsor||University Hospital Muenster|
|Start date||March 2004|
|End date||March 2005|
|Trial size||50 participants|
|Trial identifier||NCT00204256, Iron-Predialysis-2003, Ven-PD-03|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Change in hemoglobin from baseline to day 43
Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events
Male or female participants at least 18 years old.
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
|Official title||Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease|
|Principal investigator||Roland M Schaefer, MD|
|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.|
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