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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

Tracking Information
First Submitted Date  ICMJE December 16, 2016
First Posted Date  ICMJE December 28, 2016
Last Update Posted Date March 13, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
Levels of plasma lipoproteins [ Time Frame: up to 10 months ]
ion mobility lipoprotein analysis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03004001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • Levels of PCSK9 [ Time Frame: up to 10 months ]
    immunoassay
  • Triglyceride-rich lipoproteins (Remnants) [ Time Frame: up to 10 months ]
    immunoassay
  • Lipidomics [ Time Frame: up to 10 months ]
    mass spectroscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
Official Title  ICMJE Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nephrotic Syndrome
Intervention  ICMJE
  • Drug: Alirocumab
    150 mg biweekly
    Other Name: Praluent
  • Drug: Alirocumab placebo
    placebo
    Other Name: Praluent placebo
  • Drug: Atorvastatin
    20 mg/day
    Other Name: Lipitor
Study Arms  ICMJE
  • Experimental: Alirocumab and atorvastatin
    Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
    Interventions:
    • Drug: Alirocumab
    • Drug: Atorvastatin
  • Placebo Comparator: Alirocumab placebo and atorvastatin
    Alirocumab placebo biweekly and atorvastatin 20 mg/d
    Interventions:
    • Drug: Alirocumab placebo
    • Drug: Atorvastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 22, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03004001
Other Study ID Numbers  ICMJE VA16-029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Gloria Vega, Dallas VA Medical Center
Study Sponsor  ICMJE Gloria Vega
Collaborators  ICMJE
  • Regeneron Pharmaceuticals
  • Aventis Pharmaceuticals
Investigators  ICMJE
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
PRS Account Dallas VA Medical Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP