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NCT Number: NCT06800651

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)

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Key information

About this study

Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive ADPKD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JMKX003142 will be administered orally

Drug

JMKX003142 will be administered orally

Plcacebo

Drug

matched to JMKX003142

Primary outcomes

  1. Percentage Change of TKV from baseline to Week 52

    Time frame: 52 weeks

Secondary outcomes

  1. Annual rate of change in eGFR from baseline to Week 52

    Time frame: 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

xiaojun zhou

CONTACT

[email protected]

+8613717736760

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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