Edema Secondary, Edema Leg
Conditions
Keywords
renal edema, edema due to kidney diseases, Diuretic resistance
Brief summary
To evaluate the safety,efficacy, and pharmacokinetic characteristics of JMKX003142 administered randomly, double-blind, placebo-controlled study in Chinese renal edema patients with inadequate response to conventional diuretic therapy.
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 who have an inadequate response to conventional diuretic therapy. This phase 2 study is designed as a randomly, double-blind,placebo-controlled study.
Interventions
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily（one hour after meals）for seven days.
DRUGPlacebo Tablets
Placebo tablets for matched group.Take the placebo tablets once daily （one hour after meals）for seven days.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * At the start of the run-in period,patients must have been receiving either a loop diuretic at a dose equivalent to ≥40 mg of furosemide or a combination of any dose of a loop diuretic with a diuretic of another class (different mechanism of action). * Body weight change of \<1.0 kg during the run-in period.No changes in the conventional diuretic regimen during the run-in period.
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; * 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≥180 mmHg/diastolic blood pressure ≥110mmHg; * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight | Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urine volume | Day 1 to day 7 |
| Bodyweight | Day 2 to day 7 |
| Improvement rate of edema in both lower limbs | Day 8 |
| Adverse events,vital signs,physical examination | Throughout the entire experimental period |
| PK parameter | Day 1、2、6 and 7 |
Countries
China
Outcome results
None listed