A Multicenter,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
To evaluate the safety,efficacy, and pharmacokinetic characteristics of JMKX003142 administered randomly, double-blind, placebo-controlled study in Chinese renal edema patients with inadequate response to conventional diuretic therapy.
详细描述
JMKX003142 is an arginine vasopressin（AVP）-V2R antagonist which shows a remarkable diuretic effect in healthy volunteers.In this phase 2 study ，we will observe the safety 、efficacy and pharmacokinetic（PK） characteristics about different dose levels of JMKX003142 tablets in renal edema who have an inadequate response to conventional diuretic therapy. This phase 2 study is designed as a randomly, double-blind,placebo-controlled study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who can fully understand the purpose and process of the study and voluntarily sign the informed consent form（ICF）;
- •Age ≥ 18 years old during screening;
- •Diagnosed as renal edema during screening;
- •Estimated glomerular filtration rate（eGFR） ≥ 15 mL/min/1.73m2 during screening.
- •At the start of the run-in period,patients must have been receiving either a loop diuretic at a dose equivalent to ≥40 mg of furosemide or a combination of any dose of a loop diuretic with a diuretic of another class (different mechanism of action).
- •Body weight change of <1.0 kg during the run-in period.No changes in the conventional diuretic regimen during the run-in period.
排除标准
- •Patients who are receiving the renal replacement therapy during screening or patients who require renal replacement therapy in the short term evaluated by the researchers;
- •Patients who are suspected with hypovolemia;
- •Patients with the following diseases or symptoms: acute thrombosis, diarrhea, and difficulty urinating;
- •Patients who are unable to sense thirst or who have difficulty with fluid intake;
- •Patients who have received arginine vasopressin-V2R blockers within 30 days prior to the screening examination;
- •The following laboratory indicators are abnormal: glutamic pyruvic transaminase ≥ 1.5 ×upper limit of normal, glutamic oxaloacetic transaminase ≥ 1.5 × upper limit of normal, serum sodium> upper limit of normal;
- •Patients who received diuretics or treatments with diuretic effects from Day-2 to randomization;
- •During screening, systolic blood pressure <90mmHg/diastolic blood pressure<60mmHg, systolic blood pressure≥180 mmHg/diastolic blood pressure ≥110mmHg;
- •Patients who have a history of allergies to ≥ 3 substances, or are currently in an allergic state;
- •Female patients who are breast-feeding or who have a positive pregnancy test result prior to receiving investigational product (IMP);
- •Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice birth control or remain abstinent during the trial and for 30 days after the final IMP administration.
研究组 & 干预措施
low dose group
low dose of JMKX003142 tablets，take orally once daily，last for 7 days
干预措施: JMKX003142 tablets (Drug)
high dose group
high dose of JMKX003142 tablets，take orally once daily，last for 7 days
干预措施: JMKX003142 tablets (Drug)
Matched group
placebo take orally once daily，last for 7 days
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
body weight
时间窗: Day 8
次要结局
- Adverse events,vital signs,physical examination(Throughout the entire experimental period)
- PK parameter(Day 1、2、6 and 7)
- 24-hour urine volume(Day 1 to day 7)
- Bodyweight(Day 2 to day 7)
- Improvement rate of edema in both lower limbs(Day 8)