Statin Therapy in Patients With Early Stage ADPKD
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Total Kidney Volume
研究概览
简要总结
This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an investigational drug for treatment of ADPKD.
详细描述
This is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and benefits of pravastatin therapy in adults with ADPKD by evaluating 1) kidney volume as measured by kidney magnetic resonance imaging (MRI); 2) renal blood flow as measured by kidney magnetic resonance angiography (MRA); 3) kidney function as assessed by Glofil-125; 4) plasma and urine protein markers that will allow a better understanding of how pravastatin works in ADPKD; and 5) blood vessel stiffness as measured by carotid-femoral pulse wave velocity. These parameters will be measured at baseline and after 2 years of pravastatin or placebo treatment in 150 patients with ADPKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADPKD
- •Total kidney volume >500 mL
- •Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73m^2
- •Controlled blood pressure <140/80 mmHg
排除标准
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury
- •Unstable angina
- •Coronary artery disease
- •Prior ischemic stroke
- •Other clinical indication for a statin
- •History of hospitalizations within the last 3 months
- •Hepatic impairment or liver function abnormalities
- •Secondary hypercholesterolemia or hypocholesterolemia
- •Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine
- •Hypersensitivity to statins
- •Immunosuppressive therapy within the last year
- •Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia)
- •Hypersensitivity to iodine
- •Pregnant or breast feeding
- •Current tobacco use
- •Alcohol abuse or dependence
研究组 & 干预措施
Placebo
Participants will receive inactive 40 mg tablets of placebo everyday for 6 weeks. If well tolerated, participants will continue taking inactive 40 mg dose of placebo everyday for 2 years.
干预措施: Placebo (Drug)
Pravastatin
Participants will receive 40 mg tablets of pravastatin everyday for 6 weeks. If well tolerated, participants will continue taking 40 mg dose of pravastatin everyday for 2 years.
干预措施: Pravastatin (Drug)
结局指标
主要结局
Change in Total Kidney Volume
时间窗: Baseline, 2 years
Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment
次要结局
- Change in Circulating Inflammatory Markers(Baseline, 2 years)
- Change in Renal Blood Flow(Baseline, 2 years)
- Change in Kidney Function(Baseline, 2 years)
- Change in Circulating Markers of Oxidative Stress(Baseline, 2 years)
- Change in Urinary Epithelial Cells(Baseline, 2 years)