Hypercholesterolemia Clinical Trial
Official title:
A Phase III Trial to Evaluate the Efficacy and Safety of Biweekly Alirocumab in Patients on a Stable Dialysis Regimen: The Alidial Study
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 Ten patients maintained on stable hemodialysis for a minimum of 3 months
and ten patients maintained on stable peritoneal dialysis for a minimum of 3 months
Test product: alirocumab 150 mg
Mode of administration: administered subcutaneously
Dosing interval: every 2 weeks
Duration of treatment: 12 weeks
Primary endpoint: Levels of LDL-cholesterol at 12 weeks
Secondary endpoints: Levels of total cholesterol, triglycerides, apoprotein B, Cystatin-C,
fibrinogen, hsCRP, IL-6, NGAL, NT-proBNP, soluble CD40 ligand, troponin T, VCAM
Safety criteria: Adverse events, Incidence and intensity of AE, including serious AE (SAE),
Withdrawal from study medication due to AE, Clinical relevant new findings or worsening of
existing conditions physical examination, Clinically relevant changes in laboratory
measurements from baseline
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