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

Peritoneal Dialysis Clinical Trial

Official title:

Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00291863
• Other study ID #: 0089/04
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2006
• Last updated: February 15, 2006
• Start date: February 2006
• Est. completion date: February 2006

Study information

• Verified date: February 2006
• Source: Federal University of São Paulo
• Contact: Maristela Bohlke, MD
• Phone: 55 53 32264098
• Email: mbohlke[@]conesul.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Peritoneal Dialysis
• Renal Failure, End Stage
• Renal Insufficiency

Intervention

Drug:
• Simvastatin

Locations

Country	Name	City	State
Brazil	São Lucas Hospital	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial venodilation
Secondary	Inflammation markers (C-reactive protein, IL-6, TNF)
Secondary	Lipoproteins
Secondary	Oxidative stress