A Multicenter,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients

Led by Jemincare · Updated on 2026-08-10

133

Participants Needed

Research Sites

2 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

A Dose-finding Study of JMKX003142 in Treatment of Renal Edema

Who Can Participate

Age: 18Years +

All Genders

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).
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 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.

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A Multicenter,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria