A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
NCT ID: NCT00680563
Last Updated: 2013-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
4 participants
INTERVENTIONAL
2009-04-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* no ESA therapy during previous 3 months;
* adequate iron status;
* rapid chronic kidney disease progression.
Exclusion Criteria
* poorly controlled hypertension requiring hospitalization in previous 6 months;
* significant acute or chronic bleeding.
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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Buenos Aires, , Argentina
La Plata, , Argentina
San Miguel de Tucumán, , Argentina
Blumenau, , Brazil
Botucatu, , Brazil
Curitiba, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Santiago, , Chile
Santiago, , Chile
Barranquilla, , Colombia
Cali, , Colombia
Envigado, , Colombia
Medellín, , Colombia
San José, , Costa Rica
Quito, , Ecuador
Guatemala City, , Guatemala
Panama City, , Panama
Lima, , Peru
San Isidro, , Peru
Caracas, , Venezuela
Countries
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Other Identifiers
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ML21467
Identifier Type: -
Identifier Source: org_study_id