A Dose-finding Study of JMKX003142 in Treatment of Renal Edema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
To Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of JMKX003142 Administered Randomly, Open-label, Active-controlled Study in Chinese Renal Edema Patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
DrugJMKX003142 tablets for experimental groups.Take the JMKX003142 tablets（on empty stomach） once daily for seven days.
Torasemide tablets
DrugTorasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.
Treatment groups
216 Participants
are divided into 4 treatment groupsGroup A: low dose groupExperimental treatment 1 intervention
Group B: median dose groupExperimental treatment 1 intervention
Group C: high dose groupExperimental treatment 1 intervention
Group D: active comparator groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
body weight
Time frame
7 days Source ClinicalTrials.gov