A Study of NeoRecormon in Patients With Chronic Kidney Disease.
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4|
- Hb level, decline in renal function, 24h proteinuria, creatinine clearance. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Completion Date:||April 2008|
Drug: epoetin beta [NeoRecormon]
At a dose to achieve and maintain an Hb level of 120-135g/dL.
|No Intervention: 2|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437723
|Belgrade, Serbia, 11000|
|Novi Sad, Serbia, 21000|
|Study Director:||Clinical Trials||Hoffmann-La Roche|