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

Sponsored by Jemincare

About this trial

Last updated 8 months ago

Study ID

JMKX003142-R201

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 months ago

What is this trial about?

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

What are the participation requirements?

Yes

Inclusion Criteria

- Patients who can fully understand the purpose and process of the study and voluntarily sign the ICF;

- Age ≥ 18 years old during screening;

- Diagnosed as renal edema during screening;

- eGFR ≥ 15 mL/min/1.73m2 during screening.

No

Exclusion Criteria

- Patients who are receving 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 AVP-V2R blockers within 30 days prior to the screening examination;

- The following laboratory indicators are abnormal: ALT ≥ 1.5 × ULN, AST ≥ 1.5 × ULN, serum sodium>ULN, D-dimer ≥ 2 × ULN;

- Patients who received diuretics or treatments with diuretic effects from Day-2 to randomization;

- During screening, SBP <90mmHg/DBP<60mmHg, SBP>160mmHg/DBP >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.