A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00081484

BA17284

Details and patient eligibility

About

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Enrollment: 336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• on dialysis therapy for at least 12 weeks before screening;
• receiving iv or sc epoetin for at least 8 weeks before screening.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

Active Comparator group

Treatment:

Drug: epoetin alfa or beta