A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon

This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.

Inclusion Criteria:

• adult patients, 18-80 years of age;
• stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
• Hb <100g/L, TSAT>=20%, and ferritin >=100 mcg/L at screening.

Exclusion Criteria:

• anticipating to go on renal replacement therapy;
• anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
• uncontrolled hypertension;
• congestive heart failure;
• active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.