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

Jemincare

Status and phase

Enrolling

Phase 2

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Treatments

Drug: Plcacebo

Drug: JMKX003142 will be administered orally

Study type

Interventional

Funder types

Industry

Identifiers

NCT06800651

JMKX003142-A203

Details and patient eligibility

About

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)

Full description

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

Enrollment

135 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.