NCT06670534

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Jemincare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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 patients. This phase 2 study is designed as a randomly, open-label, active-controlled study.

Conditions

• Edema Secondary
• Edema Leg

Interventions

Type	Name	Description
DRUG	JMKX003142 tablets	JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
DRUG	Torasemide tablets	Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-07-15
• Completion: 2026-07-30
• First posted: 2024-11-01
• Last updated: 2025-08-12

Locations

2 sites across 1 country: China