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

First Received on February 14, 2006. Last Updated on February 15, 2006 History of Changes

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:	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:

MedlinePlus related topics: Dialysis 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:

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 February 09, 2012