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

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442793

ML20680

Details and patient eligibility

About

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic renal anemia requiring dialysis;
• maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
• adequate iron status.

Exclusion criteria

• previous epoetin treatment within 8 weeks prior to screening;
• failing renal graft in place;
• bleeding episode necessitating transfusion within 8 weeks 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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265 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

Active Comparator group

Treatment:

Drug: Epoetin beta