A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
NCT ID: NCT00048048
Last Updated: 2018-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2002-03-31
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week)
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.
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* not receiving renal replacement therapy.
Exclusion Criteria
* administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Detroit, Michigan, United States
Las Vegas, Nevada, United States
Portland, Oregon, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Mexico City, , Mexico
Monterrey, , Mexico
Gdansk, , Poland
Krakow, , Poland
Wroclaw, , Poland
Belfast, , United Kingdom
London, , United Kingdom
Birmingham, Alabama, United States
San Diego, California, United States
Detroit, Michigan, United States
Countries
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Other Identifiers
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BA16528
Identifier Type: -
Identifier Source: org_study_id
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