ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Conditions
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
Interventions
JMKX003142 will be administered orally
DRUGPlcacebo
matched to JMKX003142
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change of TKV from baseline to Week 52 | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Annual rate of change in eGFR from baseline to Week 52 | 52 weeks |
Countries
China
Contacts
Primary Contactxiaojun zhou
Outcome results
None listed