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Recruiting Phase 2 NCT06670534

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

Trial Parameters

Condition Edema Secondary
Sponsor Jemincare
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 216
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-07
Completion 2026-07-15
Interventions
JMKX003142 tabletsTorasemide tablets

Brief Summary

To Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of JMKX003142 Administered Randomly, Open-label, Active-controlled Study in Chinese Renal Edema Patients.

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. 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 transamina

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