Menu
Recruiting NCT06670534

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

Phase II Interventional Edema Secondary Edema Leg

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JMKX003142 tablets, Torasemide tablets.
Who it may be relevant to
Registry conditions: Edema Secondary, Edema Leg. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • body weight [Time frame: 7 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Fudan University Affiliated Zhongshan Hospital — Shanghai
  • Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare） — Shanghai

Identifiers

NCT: NCT06670534 · JMKX003142-R201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗