ADPKD (Autosomal Dominant Polycystic Kidney Disease)Phase 2NCT06800651
Trial of JMKX003142 in Participants With Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 2 study testing JMKX003142 will be administered orally and Plcacebo in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease), run by Jemincare at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADPKD (Autosomal Dominant Polycystic Kidney Disease)
- What is being tested?
- JMKX003142 will be administered orally and Plcacebo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to 30 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hong Zhang, Ph.D, 010-83572211, hongzh@bjmu.edu.cn
About this study
Official title: 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)
Read the detailed description
Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive ADPKD
- Being tested
- JMKX003142 will be administered orally, Plcacebo
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003142 will be administered orallyDrug
JMKX003142 will be administered orally
PlcaceboDrug
matched to JMKX003142
| Study group | Role | What they receive |
|---|---|---|
| JMKX003142 | Experimental | Not described Receives: Drug: JMKX003142 will be administered orally |
| placebo | Placebo comparator | Not described Receives: Drug: Plcacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change of TKV from baseline to Week 52
Measured: 52 weeks
Secondary outcomes (1)
Annual rate of change in eGFR from baseline to Week 52
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start13 Mar 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADPKD (Autosomal Dominant Polycystic Kidney Disease)Studies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, Ph.D, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800651
- Sponsor's protocol ID
- JMKX003142-A203
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06800651
- Acronym / sponsor ID
- JMKX003142-A203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JMKX003142 | Experimental | Drug: JMKX003142 will be administered orally |
| placebo | Placebo comparator | Drug: Plcacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMKX003142 will be administered orallyJMKX003142 will be administered orally | Drug | JMKX003142 |
| Plcacebomatched to JMKX003142 | Drug | placebo |
Primary outcome
Percentage Change of TKV from baseline to Week 52
Time frame: 52 weeks
1 secondary outcome
Annual rate of change in eGFR from baseline to Week 52
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Zhang, Ph.D study chair
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JMKX003142 will be administered orally and Plcacebo in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease), run by Jemincare at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaojun zhou (+8613717736760, zhouxiaojun@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change of TKV from baseline to Week 52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.