RecruitingPhase 2NCT06670534

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

A Multicenter,Randomized,Open-label,Positive-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients


Sponsor

Jemincare

Enrollment

216 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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, 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.

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Interventions

DRUGJMKX003142 tablets

JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets(on empty stomach) once daily for seven days.

DRUGTorasemide tablets

Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.


Locations(2)

Fudan University Affiliated Zhongshan Hospital

Shanghai, China

Zhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare)

Shanghai, China

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NCT06670534


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