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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03004001
Recruitment Status : Terminated (Difficult recruitment)
First Posted : December 28, 2016
Last Update Posted : October 6, 2020
Regeneron Pharmaceuticals
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Gloria Vega, Dallas VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Alirocumab Drug: Alirocumab placebo Drug: Atorvastatin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
Study Start Date : January 2017
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Alirocumab and atorvastatin
Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
Drug: Alirocumab
150 mg biweekly
Other Name: Praluent

Drug: Atorvastatin
20 mg/day
Other Name: Lipitor

Placebo Comparator: Alirocumab placebo and atorvastatin
Alirocumab placebo biweekly and atorvastatin 20 mg/d
Drug: Alirocumab placebo
Other Name: Praluent placebo

Drug: Atorvastatin
20 mg/day
Other Name: Lipitor

Primary Outcome Measures :
  1. Levels of plasma lipoproteins [ Time Frame: up to 10 months ]
    ion mobility lipoprotein analysis

Secondary Outcome Measures :
  1. Levels of PCSK9 [ Time Frame: up to 10 months ]

  2. Triglyceride-rich lipoproteins (Remnants) [ Time Frame: up to 10 months ]

  3. Lipidomics [ Time Frame: up to 10 months ]
    mass spectroscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03004001

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United States, Texas
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Gloria Vega
Regeneron Pharmaceuticals
Aventis Pharmaceuticals
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Principal Investigator: Gloria L Vega, PhD Dallas VAMC
Study Director: Yin Oo, MD Dallas VA Medical Center
Study Director: Michael Concepcion, MD Dallas VA Medical Center
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Responsible Party: Gloria Vega, Principal Investigator at Dallas VA Medical Center, Dallas VA Medical Center Identifier: NCT03004001    
Other Study ID Numbers: VA16-029
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gloria Vega, Dallas VA Medical Center:
Severe proteinuria
Additional relevant MeSH terms:
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Nephrotic Syndrome
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs