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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

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.