Edema SecondaryPhase 2NCT06670534
A Dose-finding Study of JMKX003142 in Treatment of Renal Edema
A Phase 2 study testing JMKX003142 tablets in people with Edema Secondary and Edema Leg, run by Jemincare at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema Secondary, Edema Leg
- What is being tested?
- JMKX003142 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 2 sitesChina
- Study dates
- 17 Oct 2025to 12 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Affiliated Zhongshan Hospital
Shanghai, 200102
Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare）
Shanghai, 200102
About this study
Official title: A Multicenter,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients
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.
Read the 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.
- Conditions
- Edema Secondary, Edema Leg
- Being tested
- JMKX003142 tablets, Placebo Tablets
- Keywords
- renal edema, edema due to kidney diseases, Diuretic resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003142 tabletsDrug
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily（one hour after meals）for seven days.
Placebo TabletsDrug
Placebo tablets for matched group.Take the placebo tablets once daily （one hour after meals）for seven days.
| Study group | Role | What they receive |
|---|---|---|
| low dose group | Experimental | low dose of JMKX003142 tablets，take orally once daily，last for 7 days Receives: Drug: JMKX003142 tablets |
| high dose group | Experimental | high dose of JMKX003142 tablets，take orally once daily，last for 7 days Receives: Drug: JMKX003142 tablets |
| Matched group | Placebo comparator | placebo take orally once daily，last for 7 days Receives: Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
Measured: Day 8
Secondary outcomes (5)
24-hour urine volume
Measured: Day 1 to day 7
Bodyweight
Measured: Day 2 to day 7
Improvement rate of edema in both lower limbs
Measured: Day 8
Adverse events,vital signs,physical examination
Measured: Throughout the entire experimental period
PK parameter
Measured: Day 1、2、6 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start17 Oct 2025
- Primary completion27 Apr 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema SecondaryStudies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670534
- Sponsor's protocol ID
- JMKX003142-R201
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of JMKX003142 in Renal Edema Patients
- ClinicalTrials.gov ID
- NCT06670534
- Acronym / sponsor ID
- JMKX003142-R201
- Conditions
- Edema Secondary, Edema Leg
- Keywords
- renal edema, edema due to kidney diseases, Diuretic resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose group | Experimental | Drug: JMKX003142 tabletslow dose of JMKX003142 tablets，take orally once daily，last for 7 days |
| high dose group | Experimental | Drug: JMKX003142 tabletshigh dose of JMKX003142 tablets，take orally once daily，last for 7 days |
| Matched group | Placebo comparator | Drug: Placebo Tabletsplacebo take orally once daily，last for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMKX003142 tabletsJMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily（one hour after meals）for seven days. | Drug | high dose group, low dose group |
| Placebo TabletsPlacebo tablets for matched group.Take the placebo tablets once daily （one hour after meals）for seven days. | Drug | Matched group |
Primary outcome
body weight
Time frame: Day 8
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMKX003142 tablets in people with Edema Secondary and Edema Leg, run by Jemincare at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.