Effect of PCSK9-Antibody (Alirocumab) on Dyslipidemia Secondary to Nephrotic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Levels of plasma lipoproteins
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Alirocumab and atorvastatin
Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
干预措施: Alirocumab (Drug)
Alirocumab and atorvastatin
Alirocumab 150 mg bi-weekly and atorvastatin 20 mg/d
干预措施: Atorvastatin (Drug)
Alirocumab placebo and atorvastatin
Alirocumab placebo biweekly and atorvastatin 20 mg/d
干预措施: Alirocumab placebo (Drug)
Alirocumab placebo and atorvastatin
Alirocumab placebo biweekly and atorvastatin 20 mg/d
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Levels of plasma lipoproteins
时间窗: up to 10 months
ion mobility lipoprotein analysis
次要结局
- Levels of PCSK9(up to 10 months)
- Triglyceride-rich lipoproteins (Remnants)(up to 10 months)
- Lipidomics(up to 10 months)
研究者
Gloria Vega
Principal Investigator at Dallas VA Medical Center
Dallas VA Medical Center