Effect of PCSK9-Antibody (Alirocumab) on 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.

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.