HypercholesterolemiaNCT00999453
The Effects of Lowering Low-density Lipoprotein Cholesterol Levels to New Targets on Cardiovascular Complications in Peritoneal Dialysis Patients
A study testing LDL-cholesterol in people with Hypercholesterolemia, run by Clinical Research Center for End Stage Renal Disease, Korea at 2 sites in South Korea.
Trial summary
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis patients. Although significant improvements have been made in the management of CVD in the general population, it is not known whether these interventions would result in similar benefits in end stage renal disease patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LDL-cholesterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2009to Nov 2015
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage renal disease patients treated with peritoneal dialysis for 3 or more months
- LDL cholesterol 100 mg/dl or higher within 3 months and total cholesterol level 220 mg/dl or higher
Who cannot join
- Hypersensitivity to statin, ezetimibe, fenofibrate
- Acute MI, angina, cerebrovascular accident, vascular intervention within the last 6 months
- Chronic obstructive pulmonary disease
- alanine transaminase > 3 times the upper normal limit
- creatine kinase > 3 times the upper normal limit
- Patients suffering form non-cardiac diseases with estimated survival less than 2 years
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- Inevitable of cyclosporin, warfarin use
- Currently pregnant or breast feeding
- Any condition that might limit long-term compliance (e.g., psychiatric disorders)
- Participation in another clinical trial within 30 days prior to enrollment
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Study site
Kyungpook National University Hospital, Daegu
Severance Hospital
Seoul
About this study
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis patients. Although significant improvements have been made in the management of CVD in the general population, it is not known whether these interventions would result in similar benefits in end stage renal disease patients.
Clinical studies conducted in the general population and in patients with established cardiovascular disease have found a strong independent association between lipid lowering, primarily LDL-cholesterol, and the risk of all-cause and cardiovascular mortality.
Read more
Therefore the National Cholesterol Education Panel (NCEP) has provided guidelines to lower LDL cholesterol levels to a goal of ≤100 mg/dl in patients with major risk factors of coronary heart disease. Moreover, the recent Adult Treatment Panel III (ATP III) guidelines provide an option to lower LDL cholesterol levels to a goal of <70 mg/dl in patients with very high risks for coronary heart disease.
The National Kidney Foundation K/DOQI guideline regards dialysis patients as having high risks for coronary heart disease and consequently recommends the LDL cholesterol level to be maintained under 100 mg/dl. This recommendation is in parallel to the NCEP ATP III guideline which has been proposed for the general population. However, data regarding cholesterol levels in dialysis patients have been conflicting, with some observational studies demonstrating and some not demonstrating a clear, relationship between LDL and cardiovascular end-points. In addition few randomized studies have been conducted in CKD patients.
An observational retrospective analysis of patients receiving hemodialysis, the U.S. Renal Data System Morbidity and Mortality Study, showed that the risk for cardiovascular mortality was decreased by 36 percent among patients receiving statins, compared to those who did not. Whereas, a most recent large prospective study in diabetic hemodialysis patients failed to demonstrate a significant reduction in cardiovascular endpoints with statin therapy.
Moreover, although HD and PD patients both develop chronic hypervolemia and inflammation as common findings, the relationship between risk factors and outcome may differ between these two treatment methods. The likely role of glucose from the dialysate in causing dyslipidemia in PD patients inherits a different strength of association between cholesterol level and outcome in HD and PD patients.
Therefore, this study aims to examine the clinical outcomes of treating chronic peritoneal dialysis patients with dyslipidemia to lower cholesterol levels, randomly assigning patients to either aggressive targets of LDL cholesterol of 70 mg/dl or current standard targets of LDLD cholesterol of 100 mg/dl.
- Conditions
- Hypercholesterolemia
- Being tested
- LDL-cholesterol
- Keywords
- LDL-cholesterol, Prevalent peritoneal dialysis patients with hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDL-cholesterolOther
This is a 2-arm, open label, multi-center, randomized trial comparing aggressive to standard treatment of LDL-cholesterol. After screening, randomization, participants will be seen every 3 months during the follow-up period. An LDL-cholesterol 100 mg/dL is the goal for the standard group and the target for the aggressive group is 70 mg/dL. A lipid lowering algorithm has been developed based on the NCEP-ATP III recommendation which is used as a general guideline, allowing alterations based on the individual participants needs.
| Study group | Role | What they receive |
|---|---|---|
| LDL-cholesterol 70 mg/dL or lower | Experimental | 'Experimental arm' is defined as patients treated to lower the level of low-density lipoprotein to 70 mg/dl or lower. 'Control arm' is defined as patients treated to lower low-density lipoprotein to a level of 100 mg/dl or lower. Receives: Other: LDL-cholesterol |
| LDL-cholesterol 100 mg/dL or lower | Active comparator | 'Experimental arm' is defined as patients treated to lower the level of low-density lipoprotein to 70 mg/dl or lower. 'Control arm' is defined as patients treated to lower low-density lipoprotein to a level of 100 mg/dl or lower. Receives: Other: LDL-cholesterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular complication including acute coronary syndrome, cerebrovascular infarction and cardiovascular death
Measured: 5 years (after detecting Cardiovascular complication)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center for End Stage Renal Disease, Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Investigators
- Shin-Wook Kang, M.D., PhD., Principal investigator, professor of division of Nephrology, Severance Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999453
- Sponsor's protocol ID
- A-02
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lowering Low-density Lipoprotein Cholesterol Levels to New Targets on Cardiovascular Complications in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00999453
- Acronym / sponsor ID
- A-02
- Conditions
- Hypercholesterolemia
- Keywords
- LDL-cholesterol, Prevalent peritoneal dialysis patients with hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Clinical Research Center for End Stage Renal Disease, KoreaUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Oct 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Oct 2009 (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.
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in dialysis patients. Although significant improvements have been made in the management of CVD in the general population, it is not known whether these interventions would result in similar benefits in end stage renal disease patients.
Clinical studies conducted in the general population and in patients with established cardiovascular disease have found a strong independent association between lipid lowering, primarily LDL-cholesterol, and the risk of all-cause and cardiovascular mortality.
Therefore the National Cholesterol Education Panel (NCEP) has provided guidelines to lower LDL cholesterol levels to a goal of ≤100 mg/dl in patients with major risk factors of coronary heart disease. Moreover, the recent Adult Treatment Panel III (ATP III) guidelines provide an option to lower LDL cholesterol levels to a goal of <70 mg/dl in patients with very high risks for coronary heart disease.
The National Kidney Foundation K/DOQI guideline regards dialysis patients as having high risks for coronary heart disease and consequently recommends the LDL cholesterol level to be maintained under 100 mg/dl. This recommendation is in parallel to the NCEP ATP III guideline which has been proposed for the general population. However, data regarding cholesterol levels in dialysis patients have been conflicting, with some observational studies demonstrating and some not demonstrating a clear, relationship between LDL and cardiovascular end-points. In addition few randomized studies have been conducted in CKD patients.
An observational retrospective analysis of patients receiving hemodialysis, the U.S. Renal Data System Morbidity and Mortality Study, showed that the risk for cardiovascular mortality was decreased by 36 percent among patients receiving statins, compared to those who did not. Whereas, a most recent large prospective study in diabetic hemodialysis patients failed to demonstrate a significant reduction in cardiovascular endpoints with statin therapy.
Moreover, although HD and PD patients both develop chronic hypervolemia and inflammation as common findings, the relationship between risk factors and outcome may differ between these two treatment methods. The likely role of glucose from the dialysate in causing dyslipidemia in PD patients inherits a different strength of association between cholesterol level and outcome in HD and PD patients.
Therefore, this study aims to examine the clinical outcomes of treating chronic peritoneal dialysis patients with dyslipidemia to lower cholesterol levels, randomly assigning patients to either aggressive targets of LDL cholesterol of 70 mg/dl or current standard targets of LDLD cholesterol of 100 mg/dl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDL-cholesterol 70 mg/dL or lower | Experimental | Other: LDL-cholesterol'Experimental arm' is defined as patients treated to lower the level of low-density lipoprotein to 70 mg/dl or lower. 'Control arm' is defined as patients treated to lower low-density lipoprotein to a level of 100 mg/dl or lower. |
| LDL-cholesterol 100 mg/dL or lower | Active comparator | Other: LDL-cholesterol'Experimental arm' is defined as patients treated to lower the level of low-density lipoprotein to 70 mg/dl or lower. 'Control arm' is defined as patients treated to lower low-density lipoprotein to a level of 100 mg/dl or lower. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- End-stage renal disease patients treated with peritoneal dialysis for 3 or more months
- LDL cholesterol 100 mg/dl or higher within 3 months and total cholesterol level 220 mg/dl or higher
Key exclusion criteria (10 listed)
- Hypersensitivity to statin, ezetimibe, fenofibrate
- Acute MI, angina, cerebrovascular accident, vascular intervention within the last 6 months
- Chronic obstructive pulmonary disease
- alanine transaminase > 3 times the upper normal limit
- creatine kinase > 3 times the upper normal limit
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 |
|---|---|---|
| LDL-cholesterolThis is a 2-arm, open label, multi-center, randomized trial comparing aggressive to standard treatment of LDL-cholesterol. After screening, randomization, participants will be seen every 3 months during the follow-up period. An LDL-cholesterol 100 mg/dL is the goal for the standard group and the target for the aggressive group is 70 mg/dL. A lipid lowering algorithm has been developed based on the NCEP-ATP III recommendation which is used as a general guideline, allowing alterations based on the individual participants needs. | Other | LDL-cholesterol 100 mg/dL or lower, LDL-cholesterol 70 mg/dL or lower |
Primary outcome
Cardiovascular complication including acute coronary syndrome, cerebrovascular infarction and cardiovascular death
Time frame: 5 years (after detecting Cardiovascular complication)
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 17 Mar 2017.
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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.
Shin-Wook Kang, M.D., PhD. principal investigator
professor of division of Nephrology, Severance Hospital, Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LDL-cholesterol in people with Hypercholesterolemia, run by Clinical Research Center for End Stage Renal Disease, Korea at 2 sites in South Korea.
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 10 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
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?
Cardiovascular complication including acute coronary syndrome, cerebrovascular infarction and cardiovascular death (time frame: 5 years (after detecting Cardiovascular complication)). 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 17 Mar 2017.