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

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077766

BA17283

Details and patient eligibility

About

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Enrollment: 313 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 darbepoetin alfa iv 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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313 participants in 2 patient groups

RO0503821 (1x/2 Weeks)

Experimental group

Description:

Eligible participants will be administered with RO0503821 (\[methoxy polyethylene glycol-epoetin beta\] {Mircera}) intravenously (IV), every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Darbepoetin (1x/1-2 Weeks)

Active Comparator group

Description:

Eligible participants will be administered with darbepoetin alfa IV, every week or every 2 weeks during Weeks 1 through 52.

Treatment:

Drug: Darbepoetin alfa