Stable Chronic Kidney DiseasePhase 4NCT01257009
Atorvastatin and Sympathetic Activity in Chronic Kidney Disease
A Phase 4 study testing Atorvastatin in people with Stable Chronic Kidney Disease and Hypertension, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stable Chronic Kidney Disease, Hypertension
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2009to Jul 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable chronic kidney disease
- Hypertension
Who cannot join
- renal replacement therapy
- pregnancy
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center utrecht
Utrecht, Utrecht, 3584CX
About this study
Official title: Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease
Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is standard treatment for CKD, is known to lower sympathetic activity.
The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further lower sympathetic activity in hypertensive stage 2-4 CKD patients.
Read more
Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added.
Ten other CKD patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility.
Read the detailed description
see above
- Conditions
- Stable Chronic Kidney Disease, Hypertension
- Being tested
- Atorvastatin
- Keywords
- sympathetic activity, chronic kidney disease, atorvastatin, lipitor
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Arm 1: cessation of any statin therapy for at least 6 weeks, then the first sympathetic activity measurement will be done.Subsequently, atorvastatin 20mg is added for 6 weeks. Then the second sympathetic measurement will be performed. Receives: Drug: Atorvastatin |
| 2 | Other | Patients will receive atorvastatin for 6 weeks, then the first sympathetic measurement will be done. Then atorvastatin will be stopped and 6 weeks the second measurement will be done Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic activity
Measured: 4-6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257009
- Sponsor's protocol ID
- Statin sympathetic
- Status last verified
- Nov 2010
- First submitted
- 8 Dec 2010
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Reduces Sympathetic Activity in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01257009
- Acronym / sponsor ID
- Statin sympathetic
- Conditions
- Stable Chronic Kidney Disease, Hypertension
- Keywords
- sympathetic activity, chronic kidney disease, atorvastatin, lipitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Dec 2010 (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.
Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is standard treatment for CKD, is known to lower sympathetic activity.
The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further lower sympathetic activity in hypertensive stage 2-4 CKD patients.
Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added.
Ten other CKD patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: AtorvastatinArm 1: cessation of any statin therapy for at least 6 weeks, then the first sympathetic activity measurement will be done.Subsequently, atorvastatin 20mg is added for 6 weeks. Then the second sympathetic measurement will be performed. |
| 2 | Other | Drug: AtorvastatinPatients will receive atorvastatin for 6 weeks, then the first sympathetic measurement will be done. Then atorvastatin will be stopped and 6 weeks the second measurement will be done |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable chronic kidney disease
- Hypertension
Key exclusion criteria (3 listed)
- renal replacement therapy
- pregnancy
- 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 |
|---|---|---|
| AtorvastatinAlso: Lipitor6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity | Drug | 1, 2 |
Primary outcome
Sympathetic activity
Time frame: 4-6 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atorvastatin in people with Stable Chronic Kidney Disease and Hypertension, run by UMC Utrecht at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 9 Dec 2010. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic activity (time frame: 4-6 weeks treatment). 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 9 Dec 2010.