JMKX003142 for rapidly progressive ADPKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: xiaojun zhou
• Email: zhouxiaojun@jemincare.com
• Phone: +8613717736760

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for patients with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.