A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
Phase 4
Completed
- Conditions
- Anemia
- Interventions
- Drug: epoetin beta [NeoRecormon]
- Registration Number
- NCT00413101
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- adult patients, 18-75 years of age;
- end-stage renal disease;
- on renal dialysis >= 3 months;
- receiving NeoRecormon treatment >= 3 months;
- Hb stable and <105g/L, and LVMI >160g/m2.
Exclusion Criteria
- unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
- use of any ESA other than NeoRecormon;
- acute infection;
- use of iv NeoRecormon.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 epoetin beta [NeoRecormon] -
- Primary Outcome Measures
Name Time Method Hb level, BP. Throughout study LVMI ejection fraction, ejection fraction. 12 months
- Secondary Outcome Measures
Name Time Method SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. Throughout study