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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00442702 |
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Date of registration:
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01/03/2007 |
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Primary sponsor: |
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Public title:
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A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
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Scientific title:
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An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis. |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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228 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00442702 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Israel
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Italy
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Poland
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic kidney disease, not requiring dialysis;
- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
during screening/baseline period.
Exclusion Criteria:
- overt gastrointestinal bleeding within 8 weeks before screening, or during
screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening, or during
screening/baseline period;
- active malignant disease;
- previous treatment with Mircera.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: Darbepoetin alfa
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Drug: Mircera
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Primary Outcome(s)
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Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
[Time Frame: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).]
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Secondary Outcome(s)
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Change in Hemoglobin Concentration From Baseline Over Time
[Time Frame: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.]
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Number of Participants With Red Blood Cell (RBC) Transfusions
[Time Frame: From randomization to Month 9]
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Participants With Adverse Events
[Time Frame: Randomization to Month 10 (final visit)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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