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

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

Study Overview

• Status: Recruiting
• Conditions: Edema Secondary; Edema Leg
• Intervention / Treatment: Drug: JMKX003142 tablets; Drug: Torasemide tablets

Detailed Description

JMKX003142 is an arginine vasopressin（AVP）-V2R antagonist which shows a remarkable diuretic effect in healthy volunteers.In this phase 2 study ，we will observe the safety 、efficacy and pharmacokinetic（PK） characteristics about different dose levels of JMKX003142 tablets in renal edema patients. This phase 2 study is designed as a randomly, open-label, active-controlled study.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lin Shi; Phone Number: +8617710157616; Email: shilin2@jemincare.com

Study Locations

• China
  • Shanghai, China, 200102
    • Recruiting
    • Fudan University Affiliated Zhongshan Hospital
    • Contact: Shilin; Phone Number: +8617710157616; Email: shilin2@jemincare.com
  • Shanghai, China, 200102
    • Not yet recruiting
    • Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare）
    • Contact: Shilin; Phone Number: +8617710157616; Email: shilin2@jemincare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose group; low dose of JMKX003142 tablets，take orally once daily，last for 7 days	Drug: JMKX003142 tablets; JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
Experimental: median dose group; median dose of JMKX003142 tablets，take orally once daily，last for 7 days	Drug: JMKX003142 tablets; JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
Experimental: high dose group; high dose of JMKX003142 tablets，take orally once daily，last for 7 days	Drug: JMKX003142 tablets; JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
Active Comparator: active comparator group; torasemide tablets 20mg，take orally once daily，last for 7 days	Drug: Torasemide tablets; Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
body weight	7 days

Collaborators and Investigators

• Sponsor: Jemincare

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: renal edema; edema due to kidney diseases
• Additional Relevant MeSH Terms: Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Sodium Potassium Chloride Symporter Inhibitors; Antihypertensive Agents; Torsemide
• Other Study ID Numbers: JMKX003142-R201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No