NCT06800651招募中2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Jemincare1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年3月13日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Percentage Change of TKV from baseline to Week 52
研究概览
简要总结
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
详细描述
Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive ADPKD
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the procedures of this trial and provide written informed consent voluntarily;
- •Age between 18 to 55 years, male or female;
- •ADPKD diagnostic criteria were met before randomization;
- •Rapidly progressive ADPKD criteria were met.
排除标准
- •12 weeks prior to screening, patients had taken tolvaptan or another ADPKD improvers, or patients who were assessed by the investigator to be likely to use diuretic during the trial period;
- •Praticipants who are unable to feel thirst, or have difficulty with fluid/food intake;
- •Patients who have previously received decompression surgery for renal cysts; or who received major surgery within 12 weeks before signing the ICF;
- •The investigator think that the praticipant is unable to comply with the requirements of the trial or cannot be evaluated by the trial.
研究组 & 干预措施
JMKX003142
Experimental
干预措施: JMKX003142 will be administered orally (Drug)
placebo
Placebo Comparator
干预措施: Plcacebo (Drug)
结局指标
主要结局
Percentage Change of TKV from baseline to Week 52
时间窗: 52 weeks
次要结局
- Annual rate of change in eGFR from baseline to Week 52(52 weeks)
研究者
研究点 (1)
Loading locations...
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