A Study of 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

NCT00077623

BA16740

Details and patient eligibility

About

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

Enrollment: 572 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 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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572 participants in 3 patient groups

RO0503821 (1x/2 Weeks)

Experimental group

Description:

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

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta (Mircera)

Drug: methoxy polyethylene glycol-epoetin beta (Mircera)

RO0503821 (1x/4 Weeks)

Experimental group

Description:

Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta (Mircera)

Drug: methoxy polyethylene glycol-epoetin beta (Mircera)

Epoetin Reference

Active Comparator group

Description:

Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .

Treatment:

Drug: epoetin alfa or beta