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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alirocumab and atorvastatin

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

Group Type EXPERIMENTAL

Alirocumab

Intervention Type DRUG

150 mg biweekly

Atorvastatin

Intervention Type DRUG

20 mg/day

Alirocumab placebo and atorvastatin

Alirocumab placebo biweekly and atorvastatin 20 mg/d

Group Type PLACEBO_COMPARATOR

Alirocumab placebo

Intervention Type DRUG

placebo

Atorvastatin

Intervention Type DRUG

20 mg/day

Interventions

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Alirocumab

150 mg biweekly

Intervention Type DRUG

Alirocumab placebo

placebo

Intervention Type DRUG

Atorvastatin

20 mg/day

Intervention Type DRUG

Other Intervention Names

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Praluent Praluent placebo Lipitor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No