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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Gloria Vega
Study ID
NCT03004001
Phase
PHASE2
Status
Terminated

Conditions

  • Nephrotic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2017
Status verified
Aug 2022
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab and atorvastatin
    Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
  • Placebo Comparator: Alirocumab placebo and atorvastatin
    Alirocumab placebo biweekly and atorvastatin 20 mg/d

Primary Outcome Measure

Levels of plasma lipoproteins [ Time Frame: up to 10 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
DallasVAMCDallasTexas75216-

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By research site
DallasVAMC· Dallas, TX

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