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NCT07841093
A Study of JMKX003142 Tablet to Treat Renal Edema
Conditions: Renal Edema, Nephrogenic Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 240
Sponsor: Jemincare
Location: Zhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare) Shanghai
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 Criteria
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 \ 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 \
Source: ClinicalTrials.gov (NCT07841093). StuddyBuddy aggregates publicly available trial information.