RecruitingPhase 2NCT06800651

Trial of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (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)


Sponsor

Jemincare

Enrollment

135 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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Interventions

DRUGJMKX003142 will be administered orally

JMKX003142 will be administered orally

DRUGPlcacebo

matched to JMKX003142


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06800651


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