Back to resultsSimvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis
Primary Purpose
Renal Failure, End Stage, Peritoneal Dialysis
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure, End Stage focused on measuring end stage renal failure, peritoneal dialysis, simvastatin, endothelium, vasodilation
Eligibility Criteria
Inclusion Criteria: end stage renal failure peritoneal dialysis LDL cholesterol > 100mg/dL > 18 years and < 80 years Exclusion Criteria: using statin or nitrate liver disease diabetes mellitus
Sites / Locations
- São Lucas HospitalRecruiting
Outcomes
Primary Outcome Measures
endothelial venodilation
Secondary Outcome Measures
Inflammation markers (C-reactive protein, IL-6, TNF)
Lipoproteins
Oxidative stress
Full Information
NCT ID
NCT00291863
First Posted
February 14, 2006
Last Updated
February 15, 2006
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00291863
Brief Title
Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis
Official Title
Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
5. Study Description
Brief Summary
This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.
Detailed Description
This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, End Stage, Peritoneal Dialysis
Keywords
end stage renal failure, peritoneal dialysis, simvastatin, endothelium, vasodilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
endothelial venodilation
Secondary Outcome Measure Information:
Title
Inflammation markers (C-reactive protein, IL-6, TNF)
Title
Lipoproteins
Title
Oxidative stress
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
end stage renal failure
peritoneal dialysis
LDL cholesterol > 100mg/dL
> 18 years and < 80 years
Exclusion Criteria:
using statin or nitrate
liver disease
diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maristela Bohlke, MD
Phone
55 53 32264098
Email
mbohlke@conesul.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maristela Bohlke, master
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
São Lucas Hospital
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo P Figueiredo, PhD
12. IPD Sharing Statement
Learn more about this trial
Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis
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