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

NCT06670534 | Recruiting Phase 2

• 1 other identifier: JMKX003142-R201
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Edema Secondary; Edema Leg

Keywords

renal edema; edema due to kidney diseases

Outcome Measures

Primary Outcomes (1)

• body weight

  7 days

Study Arms (4)

low dose group

EXPERIMENTAL

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

Drug: JMKX003142 tablets

median dose group

EXPERIMENTAL

median 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

active comparator group

ACTIVE COMPARATOR

torasemide tablets 20mg，take orally once daily，last for 7 days

Drug: Torasemide tablets

Interventions

JMKX003142 tablets DRUG

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

high dose group; low dose group; median dose group

Torasemide tablets DRUG

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

active comparator 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.

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, 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (2)

Fudan University Affiliated Zhongshan Hospital

Shanghai, 200102, China

RECRUITING

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

Shanghai, 200102, China

NOT YET RECRUITING

MeSH Terms

Interventions

Torsemide

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Lin Shi

CONTACT

+8617710157616; shilin2@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• 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: January 7, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)