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

NCT06800651 | Recruiting Phase 2

• 1 other identifier: JMKX003142-A203
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Outcome Measures

Primary Outcomes (1)

• Percentage Change of TKV from baseline to Week 52

  52 weeks

Secondary Outcomes (1)

• Annual rate of change in eGFR from baseline to Week 52

  52 weeks

Study Arms (2)

JMKX003142

EXPERIMENTAL

Drug: JMKX003142 will be administered orally

placebo

PLACEBO COMPARATOR

Drug: Plcacebo

Interventions

JMKX003142 will be administered orally DRUG

JMKX003142 will be administered orally

JMKX003142

Plcacebo DRUG

matched to JMKX003142

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Hong Zhang, Ph.D

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

xiaojun zhou

CONTACT

+8613717736760; zhouxiaojun@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 30, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)