ClinicalTrials.gov
ClinicalTrials.gov Menu

Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00291863
Recruitment Status : Unknown
Verified February 2006 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : February 15, 2006
Last Update Posted : February 16, 2006
Sponsor:
Information provided by:
Federal University of São Paulo

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Renal Failure, End Stage Peritoneal Dialysis Drug: Simvastatin Phase 4

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.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis
Study Start Date : February 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. endothelial venodilation

Secondary Outcome Measures :
  1. Inflammation markers (C-reactive protein, IL-6, TNF)
  2. Lipoproteins
  3. Oxidative stress

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291863


Contacts
Contact: Maristela Bohlke, MD 55 53 32264098 mbohlke@conesul.com.br

Locations
Brazil
São Lucas Hospital Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Principal Investigator: Carlos Eduardo P Figueiredo, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Maristela Bohlke, master Federal University of São Paulo
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00291863     History of Changes
Other Study ID Numbers: 0089/04
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: February 16, 2006
Last Verified: February 2006

Keywords provided by Federal University of São Paulo:
end stage renal failure
peritoneal dialysis
simvastatin
endothelium
vasodilation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Simvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors