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

Phase 2

Recruiting

• Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
• Interventions: Drug: JMKX003142 will be administered orally; Drug: Plcacebo

• Registration Number: NCT06800651
• Lead Sponsor: Jemincare

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)

Detailed Description

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

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-01-30
• Study Start: 2025-03-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03
• Primary Completion: 2027-02-28
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JMKX003142	JMKX003142 will be administered orally	-
placebo	Plcacebo	-

Primary Outcome Measures

Name	Time	Method
Percentage Change of TKV from baseline to Week 52	52 weeks

Secondary Outcome Measures

Name	Time	Method
Annual rate of change in eGFR from baseline to Week 52	52 weeks

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Peking, Beijing, China