A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 887
- 试验地点
- 2
- 主要终点
- Occurrence of AEs
研究概览
简要总结
It is a multicenter, prospective, non-interventional cohort study, in order to evaluate the safety of oral resin for treatment of hyperkalemia in Chinese patients with renal insufficiency.
详细描述
Background/Rationale:
Hyperkalaemia (HK) is a common electrolyte disturbance in clinical practice, defined as serum potassium (sK) beyond the normal range. The cut-off value for HK diagnosis is 5.0 mmol/L in most international guidelines[1, 2]. HK changes potassium ion gradient across the cell membrane and affects the excitability and conductivity of cardiomyocytes, leading to various types of arrhythmias, including ventricular arrhythmia, cardiac arrest and sudden death[3]. In the general population, the prevalence of HK is about 2-3%[4-6]. In an epidemiological survey in China, 3.86% of general outpatients experienced HK, and the proportion of patients who experienced HK increased in patients with chronic kidney disease (CKD), heart failure, diabetes and hypertension [7]. Furthermore，62% hospitalized HK patients accompanied by acute kidney injury (AKI)[8].
Treatment options for HK are well documented, and urgent therapy is indicated for rapid and substantial elevations in sK. However, for patients with modest elevations in sK without cardiac and neuromuscular manifestations, oral resin is in line with clinical practice, both calcium polystyrene sulphonate (CPS) and sodium polystyrene sulfonate (SPS), are applicable to HK caused by acute and chronic renal dysfunction.
CPS/SPS entraps potassium in the distal colon in exchange for calcium/ sodium to potassium. CPS may have an advantage over SPS because it avoids sodium retention. However, few clinical studies have evaluated the safety and efficacy of CPS/SPS in the treatment of HK. This study is expected to enhance and supplement the currently available CPS/SPS safety and effectiveness data in Chinese population in real world practice.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 year-old
- •Provision of patient informed consent prior to any study procedure
- •Patients diagnosed as CKD or AKI
- •HK (sK+ > 5.0 mmol/L) diagnosed by physicians within 1 year before Day 1
- •Currently taking CPS/SPS, or have been prescribed and agree to start taking CPS/SPS since Day 1.
排除标准
- •Being unable to comply with study-specified procedures
- •Has ever participated in current study before, or participating in any interventional study at Day 1 or within the last 3 months before Day 1.
结局指标
主要结局
Occurrence of AEs
时间窗: From enrollment to the 6th month after enrollment
Number and percentage of AEs
Occurrence of SAEs
时间窗: From enrollment to the 6th month after enrollment
Number and percentage of SAEs
Occurrence of DAEs
时间窗: From enrollment to the 6th month after enrollment
Number and percentage of DAEs
次要结局
- Occurrence of AEs judged by the investigators to be causally related to CPS/SPS(From enrollment to the 6th month after Enrollment)
- CPS/SPS dose changes(From enrollment to the 6th month after enrollment)
- Reasons for any CPS/SPS dose changes(From enrollment to the 6th month after enrollment)
- Occurrence of SAEs judged by the investigators to be causally related to CPS/SPS(From enrollment to the 6th month after Enrollment)
- Duration of CPS/SPS treatment(From enrollment to the 6th month after enrollment)
- Occurrence of DAEs judged by the investigators to be causally related to CPS/SPS(From enrollment to the 6th month after Enrollment)
- Average CPS/SPS daily dosage(From enrollment to the 6th month after enrollment)
- Frequency of different CPS/SPS dosages(From enrollment to the 6th month after enrollment)
- Change in sK tested between V1 and V2 (patients in new user group), as well as average (within patient) sK levels(From enrollment to the 6th month after enrollment)