A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open-Label Study of the Effect of NeoRecormon on Reduction of Cardiovascular Risk in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy.|
- Efficacy: Combined endpoint of all major cardiovascular events
- Efficacy: All-cardiovascular and all-cause mortality, chronic heart failure, cardiovascular intervention, hospital admissions, cardiac structure and function by ECHO cardiography, QOL. Safety: BP/antihypertension medication, AEs, lab tests.
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|Principal Investigator:||Tilman B Drueke, Prof.||unaffliated|