Renal Failure, End StagePhase 4NCT00291863
Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis
A Phase 4 study testing Simvastatin in people with Renal Failure, End Stage and Peritoneal Dialysis, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, End Stage, Peritoneal Dialysis
- What is being tested?
- Simvastatin
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- end stage renal failure
- peritoneal dialysis
- LDL cholesterol > 100mg/dL
- > 18 years and < 80 years
Who cannot join
- using statin or nitrate
- liver disease
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
São Lucas Hospital
Porto Alegre, Rio Grande do Sul
Carlos Eduardo P Figueiredo, PhD
About this study
Official title: Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis
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.
Read the 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.
- Conditions
- Renal Failure, End Stage, Peritoneal Dialysis
- Being tested
- Simvastatin
- Keywords
- end stage renal failure, peritoneal dialysis, simvastatin, endothelium, vasodilation
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial venodilation
Secondary outcomes (3)
Inflammation markers (C-reactive protein, IL-6, TNF)
Lipoproteins
Oxidative stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure, End StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Maristela Bohlke, master, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291863
- Sponsor's protocol ID
- 0089/04
- Status last verified
- Feb 2006
- First submitted
- 14 Feb 2006
- Last updated
- 16 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00291863
- Acronym / sponsor ID
- 0089/04
- Conditions
- Renal Failure, End Stage, Peritoneal Dialysis
- Keywords
- end stage renal failure, peritoneal dialysis, simvastatin, endothelium, vasodilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Feb 2006
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- end stage renal failure
- peritoneal dialysis
- LDL cholesterol > 100mg/dL
- > 18 years and < 80 years
Key exclusion criteria (3 listed)
- using statin or nitrate
- liver disease
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin | Drug | – |
Primary outcome
endothelial venodilation
3 secondary outcomes
Inflammation markers (C-reactive protein, IL-6, TNF)
Lipoproteins
Oxidative stress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maristela Bohlke, master principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with Renal Failure, End Stage and Peritoneal Dialysis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maristela Bohlke, MD (55 53 32264098, mbohlke@conesul.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial venodilation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2006; AzTrials last refreshed its copy on 6 Nov 2026.