Actively Recruiting
A Multicenter, Randomized, Open-label, Positive-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients
Led by Jemincare · Updated on 2025-08-12
216
Participants Needed
2
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes different doses of JMKX003142 tablets in patients with renal edema. This phase 2 study is designed as a randomized, open-label, and active-controlled trial conducted in China. JMKX003142 is a drug that blocks arginine vasopressin V2 receptors and has shown strong diuretic effects in healthy volunteers. Participants will be randomly assigned to one of four groups: a low-dose, median-dose, or high-dose group of JMKX003142 tablets, or an active comparator group receiving torasemide tablets. All treatments are taken orally once daily for 7 days. The study aims to observe the safety, efficacy, and pharmacokinetic characteristics of these treatments. During the study, participants will have their body weight measured after 7 days as the primary outcome. Safety and efficacy will be monitored throughout the treatment period. Participants must be at least 18 years old and diagnosed with renal edema. The study includes regular assessments to ensure participant safety and adherence to treatment, with the trial expected to complete by July 2026.
CONDITIONS
Brief Title
A Dose-finding Study of JMKX003142 in Treatment of Renal Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who can fully understand the purpose and process of the study and voluntarily sign the informed consent form
- Age 18 years or older during screening
- Diagnosed with renal edema during screening
- Estimated glomerular filtration rate (eGFR) 15 mL/min/1.73m2 or higher during screening
You will not qualify if you...
- Patients receiving renal replacement therapy during screening or expected to need it soon
- Patients suspected of having low blood volume (hypovolemia)
- Patients with acute thrombosis, diarrhea, or difficulty urinating
- Patients unable to sense thirst or with difficulty taking fluids
- Patients who used arginine vasopressin-V2R blockers within 30 days before screening
- Abnormal liver enzymes, high serum sodium, or high D-dimer levels
- Patients who received diuretics or similar treatments from 2 days before to randomization
- Blood pressure outside the range of 90/60 mmHg to 160/100 mmHg during screening
- Patients with a history of allergies to three or more substances or currently allergic
- Female patients who are breastfeeding or have a positive pregnancy test before treatment
- Sexually active males or women of childbearing potential who do not agree to use birth control or abstain during and 30 days after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take JMKX003142 tablets or torasemide tablets once daily for seven days to evaluate safety and efficacy.
Daily visits or assessments for 7 days
Trial Site Locations
Total: 2 locations
1
Fudan University Affiliated Zhongshan Hospital
Shanghai, China, 200102
Actively Recruiting
2
Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare）
Shanghai, China, 200102
Not Yet Recruiting
Research Team
L
Lin Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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