A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Roche

Status and phase: Terminated; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta; Drug: Epoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422513

ML20336

Details and patient eligibility

About

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
• CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
• average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion criteria

• failed renal transplant within 12 months prior to screening;
• poorly controlled hypertension;
• previous treatment with Mircera.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

methoxy polyethylene glycol-epoetin beta

Experimental group

Description:

120-360 micrograms (iv) monthly, starting dose

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta

Epoetin Alfa

Active Comparator group

Description:

As prescribed, (iv), 3 times weekly

Treatment:

Drug: Epoetin alfa