Health TrialsbyHealthPanel

A Study of JMKX003142 Tablet to Treat Renal Edema

ConditionsRenal EdemaNephrogenic Edema
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • JMKX003142 Tablets

    Drug

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

  • Placebo Tablets

    Drug

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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: JMKX003142 tablet groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

1

Pharmacokinetic (PK) profile of JMKX003142 tablets

Serum concentration of JMKX003142 tablets

Time frame
Day 1 and Day 7

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: