Trial | NCT03004001  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    3
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.
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 Started
Jan 31
2017
Primary Completion
Dec 31
2019
Study Completion
Dec 31
2019
Last Update
Aug 19
2022

Drug Alirocumab

150 mg biweekly

  • Other names: Praluent

Drug Alirocumab placebo

placebo

  • Other names: Praluent placebo

Drug Atorvastatin

20 mg/day

  • Other names: Lipitor

Alirocumab and atorvastatin Experimental

Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d

Alirocumab placebo and atorvastatin Placebo Comparator

Alirocumab placebo biweekly and atorvastatin 20 mg/d

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.
No Results Posted