Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06670534

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

Led by Jemincare · Updated on 2025-08-12

216

Participants Needed

2

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who understand the study purpose and voluntarily sign informed consent
  • Age 18 years or older at screening
  • Diagnosed with renal edema at screening
  • Estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73m2 or higher at screening
Not Eligible

You will not qualify if you...

  • Receiving or expected to require renal replacement therapy soon
  • Suspected hypovolemia
  • Have acute thrombosis, diarrhea, or difficulty urinating
  • Unable to sense thirst or difficulty with fluid intake
  • Received arginine vasopressin-V2R blockers within 30 days before screening
  • Abnormal liver enzymes or serum sodium above normal limits
  • Abnormal D-dimer levels above twice the upper limit
  • Received diuretics from 2 days before to randomization
  • Blood pressure outside 90/60 mmHg to 160/100 mmHg range
  • History of allergies to 3 or more substances or currently allergic
  • Breastfeeding or positive pregnancy test before treatment
  • Sexually active without agreeing to birth control or abstinence during and 30 days after treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Fudan University Affiliated Zhongshan Hospital

Shanghai, China, 200102

Actively Recruiting

2

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

Shanghai, China, 200102

Not Yet Recruiting

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Research Team

L

Lin Shi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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