A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic kidney disease;

• anemia;

• not on dialysis therapy;

• not receiving epoetin.

Exclusion Criteria:

• women who are pregnant, breastfeeding or using unreliable birth control methods;

• administration of another investigational drug within 4 weeks before screening, or during the study period.