JMKX003142 for rapidly progressive ADPKD

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)

This Phase 2 trial will test whether the oral medicine JMKX003142 is safe, well tolerated, and can slow disease progression in adults aged 18–55 with rapidly progressive ADPKD.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Jemincare (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06800651 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial comparing oral JMKX003142 to matching placebo in adults with rapidly progressive ADPKD. Eligible participants aged 18–55 who meet diagnostic and rapid-progression criteria are randomized and followed for safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy measures. Treatment is administered orally with blinded placebo control and scheduled clinic visits for monitoring and sample collection. Key exclusions include recent use of tolvaptan or other ADPKD-modifying therapies, inability to manage fluid intake or thirst, prior decompression surgery for renal cysts, or recent major surgery.

Who should consider this trial

Good fit: Adults 18–55 with a confirmed diagnosis of ADPKD who meet the trial's rapid-progression criteria and can comply with study procedures are the intended participants.

Not a fit: People who recently used tolvaptan or other ADPKD therapies, cannot manage fluid/food intake or thirst, have had recent major surgery, or are unlikely to comply with study requirements may not receive benefit from participation.

Why it matters

Potential benefit: If successful, JMKX003142 could become a new oral option that slows cyst growth and helps preserve kidney function in people with rapidly progressive ADPKD.

How similar studies have performed: Existing therapies such as tolvaptan have shown it is possible to slow ADPKD progression, but JMKX003142 is a novel agent and this Phase 2 trial is an early test of its efficacy and safety.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: xiaojun zhou

Conditions ADPKD