A Dose-finding Study of JMKX003142 in Treatment of Renal Edema (NCT06670534) | Clinical Trial Compass
RecruitingPhase 2
A Dose-finding Study of JMKX003142 in Treatment of Renal Edema
China216 participantsStarted 2025-01-07
Plain-language summary
To Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of JMKX003142 Administered Randomly, Open-label, Active-controlled Study in Chinese Renal Edema Patients.
Who can participate
Age range18 Years
SexALL
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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…