HyperlipidemiaNCT02511418
Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure
A study testing Simvastatin in people with Hyperlipidemia and Hypertension, run by Mayo Clinic.
Trial summary
This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Hypertension, Chronic Renal Failure
- What is being tested?
- Simvastatin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab)
- Serum transaminase levels (AST, ALT) 2 times the upper limit of normal
- Clinically significant medical conditions
- Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study
- Presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection
- Presence of concomitant renal artery stenosis.
About this study
This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.
- Conditions
- Hyperlipidemia, Hypertension, Chronic Renal Failure
- Being tested
- Simvastatin
- Medical subject headings
- Hyperlipidemias, Hypertension, Kidney Failure, Chronic
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.
Effect of short term HMG-CoA reductase treatment
Differences between mean values for RPF, GFR and FF at baseline versus mean values obtained for these same parameters after 4 weeks of treatment will be analyzed using two-tailed Student's paired t-test. A similar analysis will be performed regarding patient's profiles for creatinine clearance, serum creatinine, urinary protein excretion and serum lipids. All results will be expressed as mean ± standard deviations. Differences will be considered significant at P <0.05.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Fervenza, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511418
- Sponsor's protocol ID
- 475-01
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
Publications
Zand L, Torres VE, Larson TS, King BF, Sethi S, Bergstralh EJ, Angioi A, Fervenza FC. Renal hemodynamic effects of the HMG-CoA reductase inhibitors in autosomal dominant polycystic kidney disease. Nephrol Dial Transplant. 2016 Aug;31(8):1290-5. doi: 10.1093/ndt/gfv394. Epub 2015 Nov 27.
PubMed 26614268
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT02511418
- Acronym / sponsor ID
- 475-01
- Conditions
- Hyperlipidemia, Hypertension, Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Primary completion
- Jan 2007 (actual)
- First posted
- 30 Jul 2015 (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 was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab)
- Serum transaminase levels (AST, ALT) 2 times the upper limit of normal
- Clinically significant medical conditions
- Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study
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
Effect of short term HMG-CoA reductase treatment
Time frame: 4 weeks
Differences between mean values for RPF, GFR and FF at baseline versus mean values obtained for these same parameters after 4 weeks of treatment will be analyzed using two-tailed Student's paired t-test. A similar analysis will be performed regarding patient's profiles for creatinine clearance, serum creatinine, urinary protein excretion and serum lipids. All results will be expressed as mean ± standard deviations. Differences will be considered significant at P <0.05.
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 16 Mar 2023.
- Derived from this study: PubMed 26614268Zand L, Torres VE, Larson TS, King BF, Sethi S, Bergstralh EJ, Angioi A, Fervenza FC. Renal hemodynamic effects of the HMG-CoA reductase inhibitors in autosomal dominant polycystic kidney disease. Nephrol Dial Transplant. 2016 Aug;31(8):1290-5. doi: 10.1093/ndt/gfv394. Epub 2015 Nov 27.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin in people with Hyperlipidemia and Hypertension, run by Mayo Clinic.
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 0 inclusion and 7 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Effect of short term HMG-CoA reductase treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511418, which also lists 1 linked publication.
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 Mar 2023.