A Study of NeoRecormon in Patients With Chronic Kidney Disease.

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

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.

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.