A Study of Subcutaneous (sc) Mircera in Dialysis 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

NCT00364832

BA16286

Details and patient eligibility

About

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
• receiving sc epoetin alfa or beta for at least 3 months 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 preceding 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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137 participants in 9 patient groups

Cohort A (0.4/150, 1x/ Week)

Experimental group

Description:

Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 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 B (0.4/150, 1x/ 3 Weeks)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three 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 C (0.4/150, 1x/ 4 Weeks)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 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 D (0.8/150, 1x/ Week)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% 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 E (0.8/150, 1x/ 3 Weeks)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three 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 F (0.8/150, 1x/ 4 Weeks)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 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 G (1.2/150, 1x/ Week)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% 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 H (1.2/150, 1x/ 3 Weeks)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three 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 I (1.2/150, 1x/ 4 Weeks)

Experimental group

Description:

Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 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]