Overview
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
Status:
Completed
Completed
Trial end date:
2008-04-01
2008-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Epoetin Alfa
Criteria
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.