Baylor Research Institute
12-week study of the efficacy and safety of alirocumab in patients maintained stably on hemodialysis or peritoneal dialysis. Measures of cholesterol levels, drug levels, PCSK9 levels, routine chemistry and cell counts, and biomarkers will be obtained at baseline and at weeks 4, 8, 10 and 12 weeks. Safety events will be obtained throughout the study.
Primary objective: The objective of this trial is to demonstrate the efficacy of alirocumab 150 mg every 2 weeks over 12 weeks on cholesterol levels. Secondary objective: To assess the safety of treating chronic dialysis patients with alirocumab 150 mg subcutaneously every 2 weeks for 12 weeks. Secondary objective: To demonstrate the efficacy of alirocumab 150 mg every 2 weeks over 12 weeks on biomarkers. Exploratory objective: To assess alirocumab drug levels in subjects maintained on hemodialysis and peritoneal dialysis. Methodology: Open-label, nonrandomized study Number of patients Te…
Inclusion Criteria: 1. Male or female patients, ages 18 to 80 years. 2. Written informed consent will be obtained before any study assessment is performed. 3. Diagnosis of end-stage renal disease, maintained on dialysis, without dialysis complications, for at least 3 months. 4. Patients may or may not have a diagnosis of atherosclerotic disease, such as a history of myocardial infarction (MI), cardiac percutaneous coronary intervention (PCI), coronary artery bypass (CABG) surgery, atherosclerotic transient ischemic attack (TIA) or cerebrovascular attack (CVA), or peripheral arterial disease (…
Cholesterol-lowering therapy
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