NCT00291863

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
Last Updated

February 16, 2006

Status Verified

February 1, 2006

First QC Date

February 14, 2006

Last Update Submit

February 15, 2006

Conditions

Renal Failure, End StagePeritoneal Dialysis

Keywords

end stage renal failureperitoneal dialysissimvastatinendotheliumvasodilation

Outcome Measures

Primary Outcomes (1)

  • endothelial venodilation

Secondary Outcomes (3)

  • Inflammation markers (C-reactive protein, IL-6, TNF)

  • Lipoproteins

  • Oxidative stress

Interventions

SimvastatinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • end stage renal failure
  • peritoneal dialysis
  • LDL cholesterol \> 100mg/dL
  • \> 18 years and \< 80 years

You may not qualify if:

  • using statin or nitrate
  • liver disease
  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Lucas Hospital

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, ChronicAneurysm

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Maristela Bohlke, master

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maristela Bohlke, MD

CONTACT

55 53 32264098mbohlke@conesul.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Study Start

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 16, 2006

Record last verified: 2006-02

Locations

BR(1)