Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome

• Status: Terminated
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gloria Vega
• Collaborators: Aventis Pharmaceuticals; Regeneron Pharmaceuticals
• Treatments: Antibodies; Antibodies, Monoclonal; Atorvastatin; Atorvastatin Calcium

Criteria

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.