Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00125593
Eligibility Criteria:
Inclusion Criteria:
* History of chronic kidney disease (CKD): either patients who are pre-dialysis (with a plasma or serum creatinine greater than or equal to 150 micromol/l \[greater than or equal to 1.7 mg/dl\] in men, or greater than or equal to 130 micromol/l \[greater than or equal to 1.5 mg/dl\] in women); or patients on dialysis (hemodialysis or peritoneal dialysis)
* Men or women aged greater than or equal to 40 years
Exclusion Criteria:
* Definite history of myocardial infarction or coronary revascularization procedure
* Functioning renal transplant, or living donor-related transplant planned
* Less than 2 months since presentation as an acute uraemic emergency (but could be entered later, if appropriate)
* Definite history of chronic liver disease, or abnormal liver function (i.e. alanine aminotransferase \[ALT\] greater than 1.5 x upper limit of normal \[ULN\] or, if ALT not available, aspartate aminotransferase \[AST\] greater than 1.5 x ULN). (Note: Patients with a history of hepatitis were eligible provided these limits were not exceeded.)
* Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) greater than 3 x ULN
* Definite previous adverse reaction to a statin or to ezetimibe
* Concurrent treatment with a contraindicated drug. (Note: Patients who were temporarily taking such drugs could have been re-screened for participation in the study when they discontinued them, if appropriate.) These contraindicated drugs included: HMG-CoA reductase inhibitor ("statin"); fibric acid derivative ("fibrate"); nicotinic acid; macrolide antibiotic (erythromycin, clarithromycin); systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole); protease-inhibitors (e.g. antiretroviral drugs for HIV infection); nefazodone; ciclosporin
* Child-bearing potential (i.e. premenopausal woman who was not using a reliable method of contraception)
* Known to be poorly compliant with clinic visits or prescribed medication
* Medical history that might have limited the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00125593
Study Brief:
Protocol Section:
NCT00125593