A Study of Mircera for the Treatment of Anemia in Dialysis Patients

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077597

BA16736

Details and patient eligibility

About

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• dialysis therapy for at least 2 weeks before screening.

Exclusion criteria

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• administration of any investigational drug within 4 weeks before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

Active Comparator group

Treatment:

Drug: epoetin