A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. 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: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon|
- Hb level, BP. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- LVMI ejection fraction, ejection fraction. [ Time Frame: 12 months ] [ 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:||March 2008|
Drug: epoetin beta [NeoRecormon]
At a dose to achieve and maintain an Hb level of 120-135g/L