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

NCT06670534 | Completed Phase 2

• 1 other identifier: JMKX003142-R201
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

Brief Summary

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

Edema Secondary; Edema Leg

Keywords

renal edema; edema due to kidney diseases; Diuretic resistance

Outcome Measures

Primary Outcomes (1)

• body weight

  Day 8

Secondary Outcomes (5)

• 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

Study Arms (3)

low dose group

EXPERIMENTAL

low dose of JMKX003142 tablets，take orally once daily，last for 7 days

Drug: JMKX003142 tablets

high dose group

EXPERIMENTAL

high dose of JMKX003142 tablets，take orally once daily，last for 7 days

Drug: JMKX003142 tablets

Matched group

PLACEBO COMPARATOR

placebo take orally once daily，last for 7 days

Drug: Placebo Tablets

Interventions

JMKX003142 tablets DRUG

JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily（one hour after meals）for seven days.

high dose group; low dose group

Placebo Tablets DRUG

Placebo tablets for matched group.Take the placebo tablets once daily （one hour after meals）for seven days.

Matched group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (2)

Fudan University Affiliated Zhongshan Hospital

Shanghai, 200102, China

Location

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

Shanghai, 200102, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: October 17, 2025
• Primary Completion: April 27, 2026
• Study Completion: May 12, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)