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

Jemincare

Status and phase: Not yet enrolling; Phase 2

Conditions: Edema Secondary; Edema Leg

Treatments: Drug: JMKX003142 tablets; Drug: Torasemide tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06670534

JMKX003142-R201

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 4 patient groups

low dose group

Experimental group

Description:

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

Treatment:

Drug: JMKX003142 tablets

median dose group

Experimental group

Description:

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

Treatment:

Drug: JMKX003142 tablets

high dose group

Experimental group

Description:

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

Treatment:

Drug: JMKX003142 tablets

active comparator group

Active Comparator group

Description:

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

Treatment:

Drug: Torasemide tablets