NCT01215747已完成3 期
International Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of KIACTA in Preventing Renal Function Decline in Patients With AA Amyloidosis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 45
- 主要终点
- Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD)
研究概览
简要总结
The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •females must be of nonchildbearing potential (more than 1 yr postmenopausal)or use effective contraception for at least 2 months prior to the baseline visit and through 30 days after the last dose of study medication
- •confirmed diagnosis of AA amyloidosis demonstrated by positive biopsy using congo red staining and immunohistochemistry or immunoelectronmicroscopy. Mass spectroscopy will be used upon approval of the sponsor on a case to case basis.
- •persistent proteinuria greater than 1 g/24h at 2 distinct 24-hr urine collections
- •must have CrCl greater than 25 ml/min/1.73 m2 at 2 distinct 24 hr urine collections
排除标准
- •evidence or suspicion of chronic kidney disease secondary to a disease other than AA amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney disease, recurring polynephritis, or systemic lupus erythematosus)
- •history of kidney transplantation
- •evidence or suspicion of a cause of potentially reversible acute renal failure within 3 months prior to baseline visit
- •presence of concomitant diseases or medication that could interfere with the interpretation of study results or compromise patient safety
- •presence of condition that could reduce life expectancy to less than 2 yrs
- •Type 1 or 2 diabetes mellitus
- •significant hepatic enzyme elevation
- •unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 6 months prior to the baseline visit; presence of NY Heart Assoc class III or IV heart failure
- •presence of, or history of stroke or transient ischemic attack within 6 months prior to baseline visit
- •initiation of, or any changes in, angiotensin converting enzyme inhibitor, angiotensin II receptor antagonist therapy, or renin inhibitor within 3 months prior to baseline visit
- •initiation of, or any changes in, cytotoxic agents, anti-tumor necrosis factor agents, anti interleukin-1 or 6 agents, or colchicine therapy within 3 months prior to baseline visit
- •previous use of Kiacta
- •history of malignancy within 5 yrs prior to study entry, except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has been surgically cured
- •use of investigational drug within 30 days prior to the first screening visit
- •active alcohol and/or drug abuse
研究组 & 干预措施
Kiacta (eprodisate disodium)
Experimental
干预措施: KIACTA (eprodisate disodium) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD)
时间窗: Up to 24 months
次要结局
- Progression to end-stage renal disease (ESRD)(baseline, every 3 months to end of study visit)
- urinary protein/creatinine ratio(screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit)
- Time from baseline to persistent decrease in CrCL of 40% or more, a persistent increase in SCr of 80% or more, progression to ESRD, or all-cause mortality(Up to 24 months)
- serum amyloid A(baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit)
- serum cystatin C over time(baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit)
- rate of change (slope) in creatinine clearance (CrCL) over time(baseline to primary endpoint, measured every 3 months to end of study visit)
- estimated glomerular filtration rate (eGFR)(screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit)
研究者
研究点 (45)
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