Trial of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJemincare
About this trial
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand the procedures of this trial and provide written informed consent voluntarily;
Age between 18 to 55 years, male or female;
ADPKD diagnostic criteria were met before randomization;
Rapidly progressive ADPKD criteria were met.
Disqualifiers
12 weeks prior to screening, patients had taken tolvaptan or another ADPKD improvers, or patients who were assessed by the investigator to be likely to use diuretic during the trial period;
Praticipants who are unable to feel thirst, or have difficulty with fluid/food intake;
Patients who have previously received decompression surgery for renal cysts; or who received major surgery within 12 weeks before signing the ICF;
The investigator think that the praticipant is unable to comply with the requirements of the trial or cannot be evaluated by the trial.
Trial design
Design model
Parallel
Treatments tested in this trial
JMKX003142 will be administered orally
DrugJMKX003142 will be administered orally
Plcacebo
Drugmatched to JMKX003142
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: JMKX003142Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage Change of TKV from baseline to Week 52
Time frame
52 weeksSecondary outcomes
1
Annual rate of change in eGFR from baseline to Week 52
Time frame
52 weeks Source ClinicalTrials.gov