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

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ClinicalTrials.gov Identifier: NCT03004001
Recruitment Status : Unknown
Verified March 2017 by Gloria Vega, Dallas VA Medical Center.
Recruitment status was:  Recruiting
First Posted : December 28, 2016
Last Update Posted : March 13, 2017
Sponsor:
Collaborators:
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)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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
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 ]
    immunoassay

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

  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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03004001


Contacts
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Contact: Peter Nguyen, BS 214 8570323 Peter.Nguyen6@va.gov
Contact: Sami Alaraj, BS 214 8570323 Sami.Alaraj@va.gov

Locations
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United States, Texas
DallasVAMC Recruiting
Dallas, Texas, United States, 75216
Contact: Sanjai Sabu    214-857-0323      
Sponsors and Collaborators
Gloria Vega
Regeneron Pharmaceuticals
Aventis Pharmaceuticals
Investigators
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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

Publications:
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Responsible Party: Gloria Vega, Principal Investigator at Dallas VA Medical Center, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT03004001     History of Changes
Other Study ID Numbers: VA16-029
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gloria Vega, Dallas VA Medical Center:
Severe proteinuria
Dyslipidemia
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Atorvastatin
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors