A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

Roche

Status and phase: Completed; Phase 2

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048035

BA16285

Details and patient eligibility

About

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• on hemodialysis therapy for at least 3 months;
• receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion criteria

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 6 patient groups

Cohort 1 (RO0503821 [0.25/150 1x/week])

Experimental group

Description:

Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 2 (RO0503821 [0.25/150 1x/2week])

Experimental group

Description:

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 3 (RO0503821 [0.4/150 1x/week])

Experimental group

Description:

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 4 (RO0503821 [0.4/150 1x/2week])

Experimental group

Description:

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 5 (RO0503821 [0.6/150 1x/week])

Experimental group

Description:

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 6 (RO0503821 [0.6/150 1x/2week])

Experimental group

Description:

Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]