Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients with CKD Stage 3b and 4
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis.
研究概览
简要总结
Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.
Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis [1]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.
Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).
Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium > 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed
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
- None
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
- •Chronic Kidney disease, stage 3 to 4b (eGFR 44-15 ml/min/1.73m^2)
- •Use of inhibitor of the renin-angiotensin system
排除标准
- •Hyperkaliemia (plasma potassium > 5.5 mmol/L) at baseline or at the start of potassium enriched diet
- •Use of potassium binders at baseline or at the start of potassium enriched diet
- •Use of dual RAAS-blockade, mineralocorticoid receptor blockers or potassium-sparing diuretics
- •Use of calcineurin inhibitors
- •Use of trimethoprim and sulfamethoxazole
- •Patients with a previous history of ventricular cardiac arrhythmia
- •Patients with a prolonged QTc time on ECG
- •Kidney transplantation patients
- •Patients with a life expectancy of < 6 months
- •Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
- •Women who are pregnant, breastfeeding or considering pregnancy in the coming 6 months.
- •Hypersensitivity to SCZ
研究组 & 干预措施
Potassium enriched diet
Patients with chronic kidney disease stage 3b to 4 will be treated for 6 weeks with a potassium enriched diet (adding +40mmol/day in the form of fruits/vegetables/nuts)
干预措施: Sodium zirconium cyclosilicate (Drug)
结局指标
主要结局
The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis.
时间窗: 6 weeks
次要结局
- Quality of life, using SF36 questionnaire(6 weeks)
- Plasma bicarbonate(6 weeks)
- Effect on stool (assessed with Bristol Stool Chart)(6 weeks)
- Per protocol analysis of difference in serum potassium after six week (end of study)(6 weeks)
- Necessity for treatment of hyperkalemia(6 weeks)
- Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours)(6 weeks)
- 24 hours albuminuria(6 weeks)
- urinary potassium (mmol/l)(6 weeks)
- Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia)(6 weeks)
- Difference in serum potassium one week after start of study (SCZ free period)(6 weeks)
- urinary sodium (mmol/l)(6 weeks)
- Incidence of hyperkalemia (serum potassium above 5.5 mmol/l)(6 weeks)
研究者
JorisRotmans
Professor
Leiden University Medical Center