Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- Renal composite outcome
研究概览
简要总结
The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] between 15-45 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design.
详细描述
The EXploring approaChEs with Lower targets of blood preSsure and lIpid for impOving Renal outcome in advanced Chronic Kidney Disease (EXCELSIOR-CKD) strived to enroll about 642 participants aged ≥19 years with eGFR 15-45 mL/min/1.73 m2, systolic blood pressure (SBP) ≥130 mmHg, and low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL.
The EXCELSIOR-CKD study is a 2X2 factorial design with factors consisting of: intensive versus standard SBP control (120 vs 140 mmHg), and intensive versus standard LDL-C control (70 vs 100 mg/dL).
The primary hypothesis was that kidney disease progression event rates would be lower in the intensive arms. Participants would be recruited at 13 clinics over approximately a 2-year period, and are planned to be followed for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of all of followings
- •At least 19 years old
- •Evidence of CKD defined at least 3 months before and at the time of screening visit with CKD-EPI eGFR ≥15 to <45 mL/min/1.73 m2
- •130-180 mmHg on 0 or 1 medication
- •130-170 mmHg on upto 2 medications
- •130-160 mmHg on more than 3 medications
- •LDL-C ≥100 mg/dL
排除标准
- •Any of followings
- •Resistant hypertension or poorly controlled hypertension
- •Failure to achieve SBP of <140 mmHg despite using 4 or more antihypertensive medications including diuretics
- •Known secondary cause of hypertension
- •History of renal devervation procedure
- •Glomerulonephritis requiring immunosuppresive agents
- •Autosomal dominant polycystic kidney disease receiving tolvaptan
- •CKD-EPI < 15 mL/min/1.73 m2 or receiving kidney replacement therapy
- •Familial hypercholesterolemia
- •Cardiovascular event or precedure (as defined as myocardial infarction, unstable angina, coronary revascularization, or stroke) within last 3 months or planning to cardiovascular procedure upcoming 3 months at the time of screening visit
- •Symptomatic heart failure within 6 months of left ventricular ejection fraction <45%
- •A medical condition likely to limit survival to less thant 3 years
- •Diagnosis of malignancy within the last 5 years or undergoing chemotherepy or radiotherapy
- •Any organ transplant
- •Advanced cirrhosis (Child-Pugh class B or C) or abnormal liver function test (alanine transaminase or aspartate transaminase ≥1.5 X upper normal limit)
- •Evidence of active inflammatory muscle disease (polymyositis or dermatomyositis) or creatine kinase elevation (≥3 X upper normal limit)
- •History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe
- •Using any drugs as followings:
- •Nicotinic acid
- •Macrolide antibiotics
- •Systemic imidazole or triazole antifungal agent
- •Protease inhibitor
- •Nefazodone
- •Immunosuppressive agents (glucocorticoid [equivalent to prednisone 10 mg/day over 4 weeks], cyclosporin, mycofenolate, azathioprine, methotrexate, cyclophosphamide, or rituximab)
- •Pregnancy or trying to become pregnant
- •Diabetes mellitus, type I
- •Diabetes mellitus, type II with HbA1c ≥10.0%
研究组 & 干预措施
Intensive SBP control and Intensive LDL-C control
Targeting SBP <120 mmHg and targeting LDL-C <70 mg/dL
干预措施: Intensive control of SBP and intensive control of LDL-C (Drug)
Intensive SBP control and Standard LDL-C control
Targeting SBP <120 mmHg and targeting LDL-C <100 mg/dL
干预措施: Intensive control of SBP and standard control of LDL-C (Drug)
Standard SBP control and Intensive LDL-C control
Targeting SBP <140 mmHg and targeting LDL-C <70 mg/dL
干预措施: Standard control of SBP and intensive control of LDL-C (Drug)
Standard SBP control and Standard LDL-C control
Targeting SBP <140 mmHg and targeting LDL-C <100 mg/dL
干预措施: Standard control of SBP and standard control of LDL-C (Drug)
结局指标
主要结局
Renal composite outcome
时间窗: up to 3 years
Renal composite outcome would be defined as one of followings: 1. A sustained decline in eGFR of 40%, 2. Initiation of kidney replacement therapy (dialysis or kidney transplantation), 3. A sustained eGFR \<10 mL/min/1.73 m2, or 4. Death from renal causes
次要结局
- Individual components of renal composite outcome(up to 3 years)
- eGFR slopes(up to 3 years)
- Cardiovascular composite outcome(up to 3 years)