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

Phase 2

Terminated

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Alirocumab; Drug: Alirocumab placebo; Drug: Atorvastatin

• Registration Number: NCT03004001
• Lead Sponsor: Gloria Vega

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Study Start: 2017-01
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alirocumab and atorvastatin	Alirocumab	Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
Alirocumab and atorvastatin	Atorvastatin	Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
Alirocumab placebo and atorvastatin	Alirocumab placebo	Alirocumab placebo biweekly and atorvastatin 20 mg/d
Alirocumab placebo and atorvastatin	Atorvastatin	Alirocumab placebo biweekly and atorvastatin 20 mg/d

Primary Outcome Measures

Name	Time	Method
Levels of plasma lipoproteins	up to 10 months	ion mobility lipoprotein analysis

Secondary Outcome Measures

Name	Time	Method
Levels of PCSK9	up to 10 months	immunoassay
Triglyceride-rich lipoproteins (Remnants)	up to 10 months	immunoassay
Lipidomics	up to 10 months	mass spectroscopy

Trial Locations

Locations (1)

DallasVAMC; 🇺🇸 Dallas, Texas, United States