Simvastatin Effect on End Stage Renal Failure Patients Tr... | NCT00291863

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

NCT00291863

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Feb 16, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Renal Failure, End Stage
Peritoneal Dialysis

Interventions

Simvastatin

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Feb 14, 2006

First Submission Date that Met QC Criteria

Feb 14, 2006

First Posted Date

Feb 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2006

Last Update Posted Date

Feb 16, 2006Estimated

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endothelial venodilation

Secondary Outcomes

Measure	Description	Time Frame
Inflammation markers (C-reactive protein, IL-6, TNF)
Lipoproteins
Oxidative stress

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maristela Bohlke, MD	Contact	55 53 32264098		mbohlke@conesul.com.br

Overall Officials

Name	Affiliation	Role
Maristela Bohlke, master	Federal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
São Lucas Hospital	Recruiting	Porto Alegre	Rio Grande do Sul		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D051436	Renal Insufficiency, Chronic
D000783	Aneurysm

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019821	Simvastatin

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided