The study purpose is to determine the hypolipidemic effect of Alirocumab co-administered with atorvastatin on levels of triglyceride-rich lipoproteins and LDL compared to monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.
The trial is randomized (1:1 alirocumab to placebo), double-blinded, placebo-controlled with a cross-over design. The trial will last 10 months and includes a 10 week washout period between study phases.Twenty adult subjects with dyslipidemia secondary to nephrotic syndrome and treated with atorvastatin will be recruited. Alirocumab or placebo will be co-administered biweekly. Safety, efficacy chemistries, vital signs, anthropometry and monitoring for adverse events also will done at each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
DallasVAMC
Dallas, Texas, United States
Levels of plasma lipoproteins
ion mobility lipoprotein analysis
Time frame: up to 10 months
Levels of PCSK9
immunoassay
Time frame: up to 10 months
Triglyceride-rich lipoproteins (Remnants)
immunoassay
Time frame: up to 10 months
Lipidomics
mass spectroscopy
Time frame: up to 10 months
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