A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
NCT ID: NCT00737464
Last Updated: 2017-12-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2008-08-26
2009-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mircera
Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* Hb concentration 10.5g/dL - 12.5g/dL;
* continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.
Exclusion Criteria
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).
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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Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Manipal Institute of Nephrology and Urology; Nephrology
Bangalore, , India
Columbia Asia Medical Centre - Hebbal; Nephrology
Bangalore, , India
Tanker Foundation
Chennai, , India
MIOT Institute of Nephrology ; Nephrology
Chennai, , India
Madras Medical Mission Hospital
Chennai, , India
International Hospital
Guwahati, , India
Kamineni Hospitals; Nephrology
Hyderabad, , India
Nizam's Institute of Medical Sciences; Nephrology
Hyderabad, , India
Regency Hospital Ltd.; Nephrology
Kanpur, , India
Wockhardt Hospital and Kidney Institute; Nephrology
Kolkata, , India
Meerut Kidney Hospital
Meerut, , India
Silver Oaks Hospital; Nephrology
Mohali, , India
Apex Kidney Care
Mumbai, , India
Lancelot Dialysis Center
Mumbai, , India
Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
New Delhi, , India
Ruby Hall Clinic
Pune, , India
Countries
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Other Identifiers
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ML21810
Identifier Type: -
Identifier Source: org_study_id