A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic kidney disease stage V;

• on peritoneal dialysis for 3 months prior to screening;

• on epoetin alfa sc >=3 months prior to screening.

Exclusion Criteria:

• patients expecting to change dialysis modality over course of study;

• patients hospitalized during previous 3 months for any clinically significant condition;

• active malignancy;

• bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;

• transfusion of red blood cells within 3 months prior to screening.