A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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 renal anemia, with no need for dialysis expected in next 3 months;

• adequate iron status.

Exclusion Criteria:

• previous epoetin therapy within 12 weeks prior to treatment;

• transfusion of red blood cells during 2 months prior to screening;

• significant acute or chronic bleeding such as overt gastrointestinal bleeding;

• hemolysis;

• folic acid and vitamin B 12 deficiency.