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

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: RO0503821 (1x/2 Weeks); Drug: RO0503821 (1x/4 Weeks); Drug: Epoetin alfa or beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077610

BA16739

Details and patient eligibility

About

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

Enrollment: 673 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 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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673 participants in 3 patient groups

RO0503821 (1x/2 Weeks)

Experimental group

Description:

Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug.

Treatment:

Drug: RO0503821 (1x/2 Weeks)

RO0503821 (1x/4 Weeks)

Experimental group

Description:

Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug.

Treatment:

Drug: RO0503821 (1x/4 Weeks)

Epoetin (1-3x/Weeks)

Active Comparator group

Description:

Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.

Treatment:

Drug: Epoetin alfa or beta