ClinicalTrials.gg
Not yet recruitingNCT07841093Updated Sep 30, 2026

A Study of JMKX003142 Tablet to Treat Renal Edema

A Phase 3 interventional study of JMKX003142 Tablets and Placebo Tablets in Renal Edema and Nephrogenic Edema, sponsored by Jemincare. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Jemincare · Phase 3, Interventional, and Treatment

Updated Sep 30, 2026Title changedNewly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Renal Edema
  • Nephrogenic Edema

Browse trials for

Keywords

  • edema
  • renal edema
  • nephrogenic edema
  • diuretic resistance
  • edema due to kidney diseases
03

In context

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

This study's planned enrollment of 240 is above the median of 52 across 401 interventional studies indexed under Edema.

Browse Edema studies →

Lead sponsor

Jemincare is the lead sponsor of 37 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who can fully understand the purpose and process of the study and voluntarily sign the form(ICF);
  • Age ≥ 18 years old during screening;
  • Diagnosed as renal edema during screening;
  • Estimated (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.

Exclusion criteria

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 14 days prior to the randomization;
  • The following laboratory indicators are abnormal: glutamic pyruvic transaminase ≥ 1.5 ×, glutamic oxaloacetic transaminase ≥ 1.5 × upper limit of normal, serum sodium> upper limit of normal;
  • 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 product (IMP);
  • Sexually active males or women of (WOCBP) who do not agree to practice or remain abstinent during the trial and for 30 days after the final IMP administration.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    JMKX003142 tablet group

    take orally once daily,last for 7 days

    Drug: JMKX003142 Tablets

  • Placebo comparator
    placebo group

    take orally once daily,last for 7 days

    Drug: Placebo Tablets

Interventions

  • JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets once daily(one hour after meals)for seven days.

  • DrugPlacebo Tablets

    Placebo tablets for placebo group.Take the placebo tablets once daily (one hour after meals)for seven days.

06

What researchers measure

Primary outcomes

  1. Change of body weight from baseline

    Time frame: Day 8

Secondary outcomes

  1. Daily urine volume

    Time frame: Day 2 to day 7

  2. Change of body weight from baseline

    Time frame: Day 2 to day 7

  3. Daily fluid balance

    Daily fluid balance, calculated as 24-hour fluid intake minus 24-hour urine output

    Time frame: Day 1 to Day 7

  4. Resolution rate of lower limb edema

    Time frame: Day 2 to day 8

  5. 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.

    Time frame: From the first dose through 7 days after the last dose

Other outcomes

  1. Pharmacokinetic (PK) profile of JMKX003142 tablets

    Serum concentration of JMKX003142 tablets

    Time frame: Day 1 and Day 7

07

Study locations

1 site
  • Zhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare)
    Shanghai, 200102, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2027; primary completion for Apr 2028, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2026
First posted
Sep 25, 2026
StartEst.
Feb 28, 2027
Primary completionEst.
Apr 30, 2028
CompletionEst.
Jul 31, 2028
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Title
Phase IIIA Study of JMKX003142 Tablet to Treat Renal Edema
Sep 30, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Sep 30, 2026
    Title Phase IIIA Study of JMKX003142 Tablet to Treat Renal Edema
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841093
Lead sponsor
Jemincare
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Feb 28, 2027 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Sep 30, 2026

Study contacts

Hongzhang Ji
Contact
jihongzhang@jeyoupharma.com
+8618261053520

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: JMKX003142

Start the discussion