JMKX003142 will be administered orally: JMKX003142 will be administered orally
Plcacebo: matched to JMKX003142
Study summary
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
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Percentage Change of TKV from baseline to Week 52 — 52 weeks
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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