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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
133
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily(one hour after meals)for seven days.
Placebo tablets for matched group.Take the placebo tablets once daily (one hour after meals)for seven days.
Fudan University Affiliated Zhongshan Hospital
Shanghai, China
Zhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare)
Shanghai, China
body weight
Time frame: Day 8
24-hour urine volume
Time frame: Day 1 to day 7
Bodyweight
Time frame: Day 2 to day 7
Improvement rate of edema in both lower limbs
Time frame: Day 8
Adverse events,vital signs,physical examination
Time frame: Throughout the entire experimental period
PK parameter
Time frame: Day 1、2、6 and 7
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