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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2027-05-30

Brief Summary

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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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Detailed Description

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

Conditions

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ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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JMKX003142

Group Type EXPERIMENTAL

JMKX003142 will be administered orally

Intervention Type DRUG

JMKX003142 will be administered orally

placebo

Group Type PLACEBO_COMPARATOR

Plcacebo

Intervention Type DRUG

matched to JMKX003142

Interventions

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JMKX003142 will be administered orally

Intervention Type DRUG

Plcacebo

matched to JMKX003142

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No