A 2-Part, Single-Blind, Phase 3 Trial Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalaemia in Chinese Subjects (The Patiromer JADE Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 29
- 主要终点
- Part A: Change from baseline in the serum potassium (sK+)
研究概览
简要总结
This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B) and a 2-week follow-up period.
详细描述
In Part A, participants who meet all eligibility criteria will initiate patiromer at an oral dose of 8.4 g (1 packet/day). The dose will be adjusted based on the serum potassium (sK+) levels.
After the completion of part A, all the participants who meet the eligibility criteria for Part B will be randomised to receive patiromer or placebo. Participants will start Part B with the same dose of patiromer they were receiving at the end Part A. However, Patiromer dose may be up- or down-titrated based on sK+ levels.
The primary objectives of the study are:
Part A - To evaluate the efficacy of patiromer for the treatment of hyperkalemia in Chinese subjects.
Part B - To evaluate the effect of withdrawing patiromer on sK+ control. To determine if the treatment with patiromer will result in continued use of renin-angiotensin-aldosterone system inhibitor (RAASi) medications.
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
- Single (Participant)
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
- •- Chinese subjects at least 18 years of age.
- •- Chronic Kidney Disease (CKD) stage 3 and
- •- Mean of 2 measurement of serum potassium higher than 5.0 and lower than 6.5 mEq/L at baseline.
- •- Subjects on any stable dose of at least 1 RAASi medication for at least 28 days before Day 0/baseline.
- •- If on antihypertensive medication, have a stable dose for 28 days before Day 0/baseline.
- •- Women of childbearing potential must agree to continue using contraception throughout the study and for 4 weeks after study completion.
排除标准
- •- Any level of hyperkalemia at Day 0/baseline that, in the opinion of the Investigator, requires emergency intervention.
- •- Type 1 diabetes or Type 2 diabetes mellitus with glycated haemoglobin (Hb A1c) higher than 10.0% at screening/Part A baseline.
- •- History of acute renal insufficiency in the past 3 months prior to the beginning of the study.
- •- Diseases affecting the hearth muscle and heart's ability to pump blood around the body
- •- Major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation.
- •- Heart or kidney transplant recipient or anticipated need for transplant during study participation
- •- Diagnosis or treatment of a malignancy in the past 2 years before Day 0/baseline.
- •- Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to Day 0/baseline.
- •- Pregnant women or breastfeeding.
研究组 & 干预措施
Part A: Patiromer
Part A: 4-week, single-arm patiromer treatment phase (4 weeks)
干预措施: Patiromer Powder for Oral Suspension (Part A) (Drug)
Part B: Placebo
Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
干预措施: Placebo (Part B) (Drug)
Part B: Patiromer
Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase
干预措施: Patiromer Powder for Orals Suspension (Part B) (Drug)
结局指标
主要结局
Part A: Change from baseline in the serum potassium (sK+)
时间窗: Week 4
Measured in milliequivalents per litre (mEq/L)
Part B: Change from Week 4 in sK+
时间窗: The earlier of: Week 8 or the date when RAASi therapy is first decreased or discontinued
Measured in mEq/L
次要结局
- Part A: Proportion of participants having an sK+ level between 3.8 and less than 5.1 mEq/L at Week 4(Week 4)
- Part B: Proportion of participants taking any RAASi medication at Week 12(Week 12)
- Part B: Proportion of subjects discontinuing/reducing RAASi medication due to hyperkalemia(From Week 4 to 2 weeks after the end of treatment)