A Study of JMKX003142 Tablet to Treat Renal Edema

NCT07841093 | Not Yet Recruiting Phase 3

• 1 other identifier: JMKX003142-R301
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy, safety, and of JMKX003142 administered randomly, double-blind, placebo-controlled study in Chinese renal edema patients with inadequate response to conventional diuretic therapy.

Conditions

Renal Edema; Nephrogenic Edema

Keywords

edema; renal edema; nephrogenic edema; diuretic resistance; edema due to kidney diseases

Outcome Measures

Primary Outcomes (1)

• Change of body weight from baseline

  Day 8

Secondary Outcomes (5)

• Daily urine volume

  Day 2 to day 7

• Change of body weight from baseline

  Day 2 to day 7

• Daily fluid balance

  Day 1 to Day 7

• Resolution rate of lower limb edema

  Day 2 to day 8

• Incidence rate of adverse events

  From the first dose through 7 days after the last dose

Other Outcomes (1)

• Pharmacokinetic (PK) profile of JMKX003142 tablets

  Day 1 and Day 7

Study Arms (2)

JMKX003142 tablet group

EXPERIMENTAL

take orally once daily，last for 7 days

Drug: JMKX003142 Tablets

placebo group

PLACEBO COMPARATOR

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.

JMKX003142 tablet group

Placebo Tablets DRUG

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

placebo 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) as the background therapy medication.
• 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 14 days prior to the randomization;
• 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（except for the background therapy medication） from Day-3 to randomization;
• During screening, systolic blood pressure \<90 mmHg;
• 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 (1)

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

Shanghai, 200102, China

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hongzhang Ji

CONTACT

+8618261053520; jihongzhang@jeyoupharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 7, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): February 28, 2027
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)