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

A Multicenter,Randomized,Double-blind,Placebo-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, double-blind, placebo-controlled study in Chinese renal edema patients with inadequate response to conventional diuretic therapy.

Study Overview

• Status: Completed
• Conditions: Edema Secondary; Edema Leg
• Intervention / Treatment: Drug: JMKX003142 tablets; Drug: Placebo 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 who have an inadequate response to conventional diuretic therapy. This phase 2 study is designed as a randomly, double-blind,placebo-controlled study.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200102
    • Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare）
  • Shanghai, China, 200102
    • Fudan University Affiliated Zhongshan Hospital

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

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 once daily（one hour after meals）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 once daily（one hour after meals）for seven days.
Placebo Comparator: Matched group; placebo take orally once daily，last for 7 days	Drug: Placebo Tablets; Placebo tablets for matched group.Take the placebo tablets once daily （one hour after meals）for seven days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
body weight	Day 8

Secondary Outcome Measures

Outcome Measure	Time Frame
24-hour urine volume	Day 1 to day 7
Bodyweight	Day 2 to day 7
Improvement rate of edema in both lower limbs	Day 8
Adverse events,vital signs,physical examination	Throughout the entire experimental period
PK parameter	Day 1、2、6 and 7

Collaborators and Investigators

• Sponsor: Jemincare

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Actual): April 27, 2026
• Study Completion (Actual): May 12, 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 10, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Diuretic resistance; 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