Renal EdemaPhase 3NCT07841093
A Study of JMKX003142 Tablet to Treat Renal Edema
A Phase 3 study testing JMKX003142 Tablets in people with Renal Edema and Nephrogenic Edema, run by Jemincare at 1 site in China.
Trial summary
To evaluate the efficacy, safety, and 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
- Renal Edema, Nephrogenic Edema
- 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
- 240 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2027to 31 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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) as the background therapy medication.
- 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 14 days prior to the randomization;
- 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（except for the background therapy medication） from Day-3 to randomization;
- During screening, systolic blood pressure <90 mmHg;
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Hangyu Pharmaceutical Co., Ltd（subsidiary of Jemincare）
Shanghai, 200102
Han Zhang, doctor, +86-021-64041990, zhang.han@zs-hospital.sh.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of JMKX003142 Tablet in the Treatment of Renal Edema
To evaluate the efficacy, safety, and 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（phase 1 study） and renal edema patients（phase 2 study）.In this phase 3 study ，we will observe the safety 、efficacy about JMKX003142 tablet in renal edema who have an inadequate response to conventional diuretic therapy. This phase 3 study is designed as a randomly, double-blind,placebo-controlled study.
- Conditions
- Renal Edema, Nephrogenic Edema
- Being tested
- JMKX003142 Tablets, Placebo Tablets
- Keywords
- edema, renal edema, nephrogenic edema, diuretic resistance, edema due to kidney diseases
- Medical subject headings
- Edema
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 placebo group.Take the placebo tablets once daily （one hour after meals）for seven days.
| Study group | Role | What they receive |
|---|---|---|
| JMKX003142 tablet group | Experimental | take orally once daily，last for 7 days Receives: Drug: JMKX003142 Tablets |
| placebo group | Placebo comparator | 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.
Change of body weight from baseline
Measured: Day 8
Secondary outcomes (5)
Daily urine volume
Measured: Day 2 to day 7
Change of body weight from baseline
Measured: Day 2 to day 7
Daily fluid balance
Daily fluid balance, calculated as 24-hour fluid intake minus 24-hour urine output
Measured: Day 1 to Day 7
Resolution rate of lower limb edema
Measured: Day 2 to day 8
Incidence rate of adverse events
Adverse Event (AE) refers to all adverse medical events that occur after participants receive the trial medication, which can manifest as symptoms, signs, diseases, or abnormalities in laboratory tests.
Measured: From the first dose through 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start28 Feb 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal EdemaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841093
- Sponsor's protocol ID
- JMKX003142-R301
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of JMKX003142 Tablet in the Treatment of Renal Edema
- ClinicalTrials.gov ID
- NCT07841093
- Acronym / sponsor ID
- JMKX003142-R301
- Conditions
- Renal Edema, Nephrogenic Edema
- Keywords
- edema, renal edema, nephrogenic edema, diuretic resistance, edema due to kidney diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 25 Sep 2026 (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 efficacy, safety, and 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（phase 1 study） and renal edema patients（phase 2 study）.In this phase 3 study ，we will observe the safety 、efficacy about JMKX003142 tablet in renal edema who have an inadequate response to conventional diuretic therapy. This phase 3 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
- 2
| Arm | Type | Receives |
|---|---|---|
| JMKX003142 tablet group | Experimental | Drug: JMKX003142 Tabletstake orally once daily，last for 7 days |
| placebo group | Placebo comparator | Drug: Placebo Tabletstake 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) as the background therapy medication.
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 14 days prior to the randomization;
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 | JMKX003142 tablet group |
| Placebo TabletsPlacebo tablets for placebo group.Take the placebo tablets once daily （one hour after meals）for seven days. | Drug | placebo group |
Primary outcome
Change of body weight from baseline
Time frame: Day 8
5 secondary outcomes
Daily urine volume
Time frame: Day 2 to day 7
Change of body weight from baseline
Time frame: Day 2 to day 7
Daily fluid balance
Time frame: Day 1 to Day 7
Resolution rate of lower limb edema
Time frame: Day 2 to day 8
Incidence rate of adverse events
Time frame: From the first dose through 7 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JMKX003142 Tablets in people with Renal Edema and Nephrogenic Edema, run by Jemincare at 1 site 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongzhang Ji (+8618261053520, jihongzhang@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body weight from baseline (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 30 Sep 2026.