Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
NCT03004001 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2022-08-19
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.
Conditions
- Nephrotic Syndrome
Interventions
- DRUG
-
Alirocumab
150 mg biweekly
- DRUG
-
Alirocumab placebo
placebo
- DRUG
-
20 mg/day
Sponsors & Collaborators
- collaborator INDUSTRY
-
Aventis Pharmaceuticals
collaborator INDUSTRY -
Gloria Vega
lead FED
Principal Investigators
-
Gloria L Vega, PhD · Dallas VAMC
-
Yin Oo, MD · Dallas VA Medical Center
-
Michael Concepcion, MD · Dallas VA Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-31
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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