A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

Roche

Status and phase

Completed

Phase 3

Conditions

Anemia

Treatments

Drug: Epoetin alfa

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00560404

ML21208

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment

233 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, >=18 years of age;
chronic renal anemia;
regular hemodialysis with the same schedule of dialysis for >=12 weeks;
maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.

Exclusion criteria

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
acute or chronic bleeding;
active malignant disease (except non-melanoma skin cancer).