Overview
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)
Description
Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive ADPKD
Eligibility
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.