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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00291863
First received: February 14, 2006
Last updated: February 15, 2006
Last verified: February 2006
History of Changes
  Purpose

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 Intervention Phase
Renal Failure, End Stage
Peritoneal Dialysis
 Drug: Simvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • endothelial venodilation

Secondary Outcome Measures:
  • Inflammation markers (C-reactive protein, IL-6, TNF)
  • Lipoproteins
  • Oxidative stress

Estimated Enrollment: 30
Study Start Date: February 2006
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00291863     History of Changes
Other Study ID Numbers: 0089/04
Study First Received: February 14, 2006
Last Updated: February 15, 2006
Health Authority: Brazil: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013