Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Nephrotic Syndrome
In brief
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.
Key facts
- Study ID
- NCT03004001
- Run by
- Gloria Vega
- People needed
- 3
- Starts
- 2017-01-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2022-08-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- DallasVAMC — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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