A Single-Blind, Placebo-Controlled Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ardelyx
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Exponential Rate of Change in Serum Potassium from Baseline
研究概览
简要总结
This phase 2, single-blind, placebo-controlled study will evaluate the onset-of-action, safety, and efficacy of RDX227675 for the treatment of hyperkalemia. Subjects who qualify are randomized into one of four treatment groups: Group 1 (Placebo qd), Group 2 (RDX227675 10 g qd), Group 3 (RDX227675 20 g qd), Group 4 (RDX227675 30 g qd).
详细描述
The study consists of a screening visit, a 7-day treatment period, and a 7-day treatment-free follow-up period.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 85 years old, inclusive
- •Two consecutive i-STAT K values ≥ 5.5 to < 6.5 mmol/L, measured a minimum of 60-minutes apart within 1 day of first RDX227675 dose on Day 1 (prior to randomization)
- •i-STAT K value ≥ 5.5 to < 6.5 mmol/L on Day 1 (prior to randomization)
- •Ability to have repeated blood draws or effective venous catheterization
- •Females of child bearing potential must have negative urine pregnancy test on Day 1 (prior to randomization)
- •Females but be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
- •Males must agree to use an appropriate method of contraception or have documented surgical sterilization
排除标准
- •Pseudohyperkalemia signs and symptoms
- •Treatment with K lowering drugs, within 7 days prior to randomization
- •Uncontrolled Type 2 diabetes, as defined as most recent historical HbA1c > 10%, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months
- •Diabetic ketoacidosis
- •Known hypersensitivity to polystyrene sulfonate
- •Significant cardiovascular or cerebrovascular events in the past 2 months
- •Severe heart failure, defined as NYHA (New York Heart Association) class IV or hospitalization to treat heart failure in previous 3 months
- •History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders, or major gastrointestinal surgery
- •Major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 3 years. History of attempted suicide or uncontrolled bipolar disorder.
- •Use of an investigational product within 30 days prior to Screening
研究组 & 干预措施
Placebo
Microcrystalline Cellulose (MCC), 2 g qd. Subjects assigned to the Placebo group will be randomly assigned in a 1:1:1 ratio to receive either one, two, or three bottles of drug per day.
干预措施: Placebo (Drug)
10 g qd
RDX227675, 10 g qd
干预措施: RDX227675 (Drug)
20 g qd
RDX227675, 20 g qd
干预措施: RDX227675 (Drug)
30 g qd
RDX227675, 30 g qd
干预措施: RDX227675 (Drug)
结局指标
主要结局
Exponential Rate of Change in Serum Potassium from Baseline
时间窗: 48 hours
Onset of Action
次要结局
- Change in Serum Potassium Levels(7 days)
- Incidence of Treatment - Emergent Adverse Events [Safety and Tolerability](7 days)