NCT03004001

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Gloria Vega · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Alirocumab	150 mg biweekly
DRUG	Alirocumab placebo	placebo
DRUG	Atorvastatin	20 mg/day

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-12-28
• Last updated: 2022-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study