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)

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)

Study Overview

• Status: Recruiting
• Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
• Intervention / Treatment: Drug: JMKX003142 will be administered orally; Drug: Plcacebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: xiaojun zhou; Phone Number: +8613717736760; Email: zhouxiaojun@jemincare.com

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Hong Zhang, Ph.D; Phone Number: 010-83572211; Email: hongzh@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Plcacebo; matched to JMKX003142
Experimental: JMKX003142	Drug: JMKX003142 will be administered orally; JMKX003142 will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage Change of TKV from baseline to Week 52	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Annual rate of change in eGFR from baseline to Week 52	52 weeks

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Study Chair: Hong Zhang, Ph.D, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Musculoskeletal Diseases; Muscular Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Joint Diseases; Genetic Diseases, Inborn; Musculoskeletal Abnormalities; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Arthrogryposis
• Other Study ID Numbers: JMKX003142-A203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No