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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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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-6pngwz |
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Date of registration:
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20/07/2011 |
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Primary sponsor: |
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Public title:
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Effects of rosuvastatin and sevelamer in coronary calcification in chronic kidney disease patients
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Scientific title:
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Effects of rosuvastatin and sevelamer in coronary calcification in chronic kidney disease patients not on dialysis |
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Date of first enrolment:
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Target sample size:
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150 |
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Recruitment status: |
other |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-6pngwz/ |
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Study type:
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Study design:
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Clinical trial,with 3 arms,
randomized,controlled,open-label, phase 4.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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MARCELO
LEMOS |
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Address:
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Rua Pedro de Toledo 282
04039-000
São Paulo
Brazil |
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Telephone:
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11- 5572-0530 |
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Email:
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lemosmm@gmail.com |
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Affiliation:
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UNIVERSIDADE FEDERAL DE SAO PAULO |
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Name:
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MARCELO
LEMOS |
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Address:
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Rua Pedro de Toledo 282
04039-000
São Paulo
Brazil |
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Telephone:
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11- 5572-0530 |
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Email:
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lemosmm@gmail.com |
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Affiliation:
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UNIVERSIDADE FEDERAL DE SAO PAULO |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients were older than 18 years and were followed by a nephrologist for at least 03 months.
Exclusion criteria: Exclusion criteria were the presence of chronic inflammatory diseases, active malignancy, human immunodeficiency virus (HIV), viral hepatitis and chronic steroids intake.
Age minimum:
18
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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Coronary calcification
C14
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Intervention(s)
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Group A - Rosuvastatin 10mg MID,for 12 months
Group B - Sevelamer 800mg TID,for 12 months
Group C - control (not using a special drug)
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Primary Outcome(s)
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Coronary calcification progression, determined by coronary tomography at study baseline and after follow up period.
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Secondary ID(s)
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CEP 0545/05
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U1111-1122-6205
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Source(s) of Monetary Support
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Hospital do Rim e Hipertensão - Brazil
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