Renoprotective Effects of Potassium Supplementation in Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 532
- 试验地点
- 4
- 主要终点
- Difference in estimated glomerular filtration rate (eGFR)
研究概览
简要总结
The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45 ml/min/1.73 m2).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD 3b or 4 (45 - 15 ml/min/1.73 m2)
- •Δ eGFR (as estimated by the CKD-EPI equation) > 2 ml/min/1.73 m2/year (in preceding ≥ 1 year with at least 3 measurements)
- •Hypertension (defined as office blood pressure > 140/90 mmHg or use of anti-hypertensive medication)
排除标准
- •Hyperkalemia (serum potassium > 5.5 mmol/l) at study visit V0
- •Medical reasons to continue dual RAAS-blockade, mineralocorticoid receptor blockers, potassium-sparing diuretics, or oral potassium binders.
- •Patients with previous history of ventricular cardiac arrhythmia
- •Patients with a life expectancy < 6 months
- •Expected initiation of renal replacement therapy < 2 years
- •Incapacitated subjects
- •Women who are pregnant, breastfeeding or consider pregnancy in the coming 2 years.
研究组 & 干预措施
Potassium Chloride
Experimental Arm 1 - Rationale is that most evidence for a positive effect of potassium comes from studies using potassium chloride
干预措施: Potassium Chloride (Dietary Supplement)
Potassium Citrate
Experimental Arm 2 - Rationale for citrate is that recent evidence indicates that alkali treatment may also be renoprotective.
干预措施: Potassium Citrate (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Difference in estimated glomerular filtration rate (eGFR)
时间窗: Two years
次要结局
- Incidence of hyperkalemia(Two years)
- All-cause mortality(Two years)
- Progression to next CKD or albuminuria class(Two years)
- Ambulatory (24-hour) blood pressure(Two years)
- Slope analysis (change in eGFR in ml/min/1.73 m2/year)(Two years)
- Cardiovascular event(Two years)
- NT-pro-BNP(Two years)
- Pulse-wave velocity(Two years)
- Bioimpedance measures(Two years)
- Doubling in serum creatinine or end-stage renal disease(Two years)
- ≥ 30% decrease in eGFR(Two years)
- 24-hour albuminuria(Two years)
- High-sensitive CRP(Two years)
- Doubling in serum creatinine or kidney failure (CKD stage 5 or start of kidney replacement therapy)(Two years)
- Spot urine albumin to creatinine ratio (UACR)(Two years)
研究者
Ewout Hoorn
Coordinating PI
Erasmus Medical Center