A Dose-finding Study of JMKX003142 in Treatment of Renal Edema
NCT ID: NCT06670534
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
216 participants
INTERVENTIONAL
2025-01-07
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low dose group
low dose of JMKX003142 tablets，take orally once daily，last for 7 days
JMKX003142 tablets
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
median dose group
median dose of JMKX003142 tablets，take orally once daily，last for 7 days
JMKX003142 tablets
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
high dose group
high dose of JMKX003142 tablets，take orally once daily，last for 7 days
JMKX003142 tablets
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
active comparator group
torasemide tablets 20mg，take orally once daily，last for 7 days
Torasemide tablets
Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.
Interventions
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JMKX003142 tablets
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
Torasemide tablets
Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old during screening;
* Diagnosed as renal edema during screening;
* Estimated glomerular filtration rate（eGFR） ≥ 15 mL/min/1.73m2 during screening.
Exclusion Criteria
* 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, D-dimer ≥ 2 × 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\>160mmHg/diastolic blood pressure \>100mmHg;
* 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.
18 Years
ALL
No
Sponsors
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Jemincare
INDUSTRY
Responsible Party
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Locations
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Fudan University Affiliated Zhongshan Hospital
Shanghai, , China
Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare）
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JMKX003142-R201
Identifier Type: -
Identifier Source: org_study_id
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