A Study of NeoRecormon in Patients With Chronic Kidney Disease.
Phase 4
Completed
- Conditions
- Anemia
- Interventions
- Drug: epoetin beta [NeoRecormon]
- Registration Number
- NCT00437723
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- adult patients,18-75 years of age;
- end-stage renal disease, not on dialysis;
- Hb <110g/L.
Exclusion Criteria
- unstable hypertension;
- acute infections;
- use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
- myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 epoetin beta [NeoRecormon] -
- Primary Outcome Measures
Name Time Method Hb level, decline in renal function, 24h proteinuria, creatinine clearance. Throughout study
- Secondary Outcome Measures
Name Time Method SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. Throughout study