Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
Lead SponsorDallas VA Medical Center
Intervention/Treatmentatorvastatin alirocumab ...
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.
150 mg biweekly
Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
Alirocumab placebo biweekly and atorvastatin 20 mg/d
Inclusion Criteria: Nephrotic Syndrome (NS) (FSGS, IMN or NS and type 2 DM) atorvastatin LDL C >= 70 mg/dl or non-HDL C >= 100 mg/dl Plasma trigycerides < 800 mg/dl. Highly effective methods of contraception for pre-menopausal women Post-menopausal women must be amenorrheic for at least 12 months. Exclusion Criteria: homozygous FH Fibrates within 6 weeks of screening visit Uncontrolled hypothyroidism Known history of hemorrhagic stroke Known history of loss of function of PCSK9 use of systemic corticosteroids unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks of randomization Previous treatment with at least a single dose of alirocumab or any other anti-PCSK9 monoclonal antibody Other conditions or situations per protocol Laboratory findings or contraindications to background therapies Warnings/precautions of use (when appropriate) as displayed in the respective national product labeling Any currently known contra-indication to study drug, pregnancy or breastfeeding of infants.