Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis - Full Text View

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00291863

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

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, Rio Grande do Sul
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

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

Antimetabolites
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Kidney Failure, Chronic
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010