Finding the right dose of JMKX003142 for kidney-related edema

A Multicenter,Randomized,Open-label,Positive-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients

This study will see if different doses of the oral drug JMKX003142 safely reduce swelling from kidney disease in adults with renal edema compared with torasemide.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT06670534 on ClinicalTrials.gov

What this trial studies

JMKX003142 is an oral arginine vasopressin V2 receptor antagonist that produced notable diuretic effects in healthy volunteers. In this randomized, open-label, active-controlled phase 2 trial, adults with renal edema will receive different dose levels of JMKX003142 or torasemide to characterize safety, efficacy, and pharmacokinetics. Key eligibility includes age ≥18 and eGFR ≥15 mL/min/1.73 m2, while patients on or expected to need renal replacement therapy, those with hypovolemia, recent V2R blocker use, or certain abnormal labs are excluded. Outcomes will include measures of fluid reduction, adverse events, and drug concentration over time.

Who should consider this trial

Good fit: Adults (≥18 years) with diagnosed renal edema who can consent, have eGFR ≥15 mL/min/1.73 m2, and are not receiving or imminently expected to require renal replacement therapy are the intended participants.

Not a fit: Patients who require or are likely to require dialysis, those with hypovolemia or inability to maintain oral intake, recent use of V2R blockers, or significant abnormal liver tests are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, JMKX003142 could provide an effective oral option to reduce fluid overload in patients with renal edema with a predictable safety and pharmacokinetic profile.

How similar studies have performed: Other V2 receptor antagonists (vaptans) have shown aquaretic diuretic effects in prior studies, though their specific benefit for renal edema is less well established.

Eligibility criteria

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.

Where this trial is running

Shanghai and 1 other locations

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

Study contacts

• Study coordinator: Lin Shi

Conditions Edema Secondary; Edema Leg; renal edema; edema due to kidney diseases