A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

Roche

Status and phase: Completed; Phase 2

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048048

BA16528

Details and patient eligibility

About

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic renal anemia;
• not receiving renal replacement therapy.

Exclusion criteria

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 9 patient groups

Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)

Experimental group

Description:

Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]