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Recruiting NCT06800651

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

Phase II Interventional ADPKD (Autosomal Dominant Polycystic Kidney Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JMKX003142 will be administered orally, Plcacebo.
Who it may be relevant to
Registry conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

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)

Detailed description

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

Interventions

  • Drug JMKX003142 will be administered orally
    JMKX003142 will be administered orally
  • Drug Plcacebo
    matched to JMKX003142

Primary outcome measures

  • Percentage Change of TKV from baseline to Week 52 [Time frame: 52 weeks]
Secondary outcome measures (1)
  • Annual rate of change in eGFR from baseline to Week 52 [Time frame: 52 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT06800651 · JMKX003142-A203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗