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

Gloria Vega

Status and phase: Terminated; Phase 2

Conditions: Nephrotic Syndrome

Treatments: Drug: Alirocumab placebo; Drug: Atorvastatin; Drug: Alirocumab

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT03004001

VA16-029

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 2 patient groups, including a placebo group

Alirocumab and atorvastatin

Experimental group

Description:

Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d

Treatment:

Drug: Alirocumab

Drug: Atorvastatin

Alirocumab placebo and atorvastatin

Placebo Comparator group

Description:

Alirocumab placebo biweekly and atorvastatin 20 mg/d

Treatment:

Drug: Atorvastatin

Drug: Alirocumab placebo