Public trial
RBR-6pngwz Effects of rosuvastatin and sevelamer in coronary calcification in chronic kidney disease patients
Date of registration: 07/20/2011 (mm/dd/yyyy)Last approval date : 07/20/2011 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Effects of rosuvastatin and sevelamer in coronary calcification in chronic kidney disease patients not on dialysis
pt-br
Efeitos da rosuvastatina e do sevelamer na calcificação coronariana nos pacientes com doença renal crônica em tratamento conservador
Trial identification
- UTN code: U1111-1122-6205
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Public title:
en
Effects of rosuvastatin and sevelamer in coronary calcification in chronic kidney disease patients
pt-br
Efeitos da rosuvastatina e do sevelamer na calcificação coronariana nos pacientes com doença renal crônica
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Scientific acronym:
-
Public acronym:
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Secondaries identifiers:
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U1111-1122-6205
Issuing authority: WHO/ICTRP
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CEP 0545/05
Issuing authority: UNIFESP-COMITÊ DE ÉTICA
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U1111-1122-6205
Sponsors
- Primary sponsor: UNIVERSIDADE FEDERAL DE SAO PAULO
- Secondary sponsor:
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Supporting source:
- Institution: Hospital do Rim e Hipertensão
Health conditions
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Health conditions:
en
Coronary calcification
pt-br
Calcificação coronariana
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General descriptors for health conditions:
en
C14 Cardiovascular diseases
pt-br
C14 Doenças cardiovasculares
es
C14 Enfermedades cardiovasculares
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Specific descriptors:
Interventions
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Interventions:
en
Group A - Rosuvastatin 10mg MID,for 12 months Group B - Sevelamer 800mg TID,for 12 months Group C - control (not using a special drug)
pt-br
Grupo A - Rosuvastatina 10mg 1x/dia, durante 12 meses Grupo B - Sevelamer 800mg 3X/dia, durante 12 meses Grupo C - controle (sem usar medicamento específico)
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Descriptors:
en
Q65 /therapy
pt-br
Q65 /terapia
es
Q65 /terapia
Recruitment
- Study status: other
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Countries
- Brazil
- Date first enrollment: 12/31/1969 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 150 - 18 - 0 - -
Inclusion criteria:
en
All patients were older than 18 years and were followed by a nephrologist for at least 03 months.
pt-br
Todos os pacientes tinham idade superior a 18 anos e seguimento por um nefrologista pelo menos por 3 meses
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Exclusion criteria:
en
Exclusion criteria were the presence of chronic inflammatory diseases, active malignancy, human immunodeficiency virus (HIV), viral hepatitis and chronic steroids intake.
pt-br
Presença de doença inflamatória crônica, câncer atual, HIV, hepatite viral e uso de corticosteróides.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase treatment other 3 open randomized-controlled 4
Outcomes
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Primary outcomes:
en
Coronary calcification progression, determined by coronary tomography at study baseline and after follow up period.
pt-br
Progressão da calcificação coronariana, determinada através da tomografia coronariana no início do estudo e no final do estudo.
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Secondary outcomes:
Contacts
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Public contact
- Full name: MARCELO MONTEBELLO LEMOS
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- Address: Rua Pedro de Toledo 282
- City: São Paulo / Brazil
- Zip code: 04039-000
- Phone: 11- 5572-0530
- Email: lemosmm@gmail.com
- Affiliation: UNIVERSIDADE FEDERAL DE SAO PAULO
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Scientific contact
- Full name: MARCELO MONTEBELLO LEMOS
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- Address: Rua Pedro de Toledo 282
- City: São Paulo / Brazil
- Zip code: 04039-000
- Phone: 11- 5572-0530
- Email: lemosmm@gmail.com
- Affiliation: UNIVERSIDADE FEDERAL DE SAO PAULO
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Site contact
- Full name: MARCELO MONTEBELLO LEMOS
-
- Address: Rua Pedro de Toledo 282
- City: São Paulo / Brazil
- Zip code: 04039-000
- Phone: 11- 5572-0530
- Email: lemosmm@gmail.com
- Affiliation: UNIVERSIDADE FEDERAL DE SAO PAULO
Additional links:
Total de Ensaios Clínicos 17441.
Existem 8770 ensaios clínicos registrados.
Existem 4835 ensaios clínicos recrutando.
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