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

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:

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:

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

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, see Learn About Clinical Studies.

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 Anticholesteremic Agents Antimetabolites	Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015