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Starting soon Phase 3

A Study of JMKX003142 Tablet to Treat Renal Edema

NCT07841093 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 3
Started
2027-02-28
Last updated
2026-09-30

Condition(s) studied

Renal EdemaNephrogenic Edema

Investigational drug(s) / intervention(s)

JMKX003142 TabletsPlacebo Tablets

JMKX003142 Tablets: JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily(one hour after meals)for seven days.

Placebo Tablets: Placebo tablets for placebo group.Take the placebo tablets once daily (one hour after meals)for seven days.

Study summary

To evaluate the efficacy, safety, and of JMKX003142 administered randomly, double-blind, placebo-controlled study in Chinese renal edema patients with inadequate response to conventional diuretic therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) as the background therapy medication. * Body weight change of \<1.0 kg during the run-in period.No changes in the conventional diuretic regimen during the run-in period. Exclusion Criteria: * 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 14 days prior to the randomization; * 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(except for the background therapy medication) from Day-3 to randomization; * During screening, systolic blood pressure \<90 mmHg; * 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.

Primary outcome measure(s)

  • Change of body weight from baseline — Day 8

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare) Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07841093 on ClinicalTrials.gov ↗ ← All trials in China