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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03004001

Enrollment

Registered

2016-12-28

Start date

2017-01-31

Completion date

2019-12-31

Last updated

2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome

Keywords

Severe proteinuria, Dyslipidemia

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.

Interventions

DRUGAlirocumab

150 mg biweekly

DRUGAlirocumab placebo

placebo

DRUGAtorvastatin

20 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Levels of plasma lipoproteins	up to 10 months	ion mobility lipoprotein analysis

Secondary

Measure	Time frame	Description
Levels of PCSK9	up to 10 months	immunoassay
Triglyceride-rich lipoproteins (Remnants)	up to 10 months	immunoassay
Lipidomics	up to 10 months	mass spectroscopy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026