Primary Membranous NephropathyPhase 1NCT05800873
Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
A Phase 1 study testing EVER001 in people with Primary Membranous Nephropathy, run by Everest Medicines (China) Co.,Ltd. at 19 sites in China.
Trial summary
EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- EVER001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 19 sitesChina
- Study dates
- 15 May 2023to 27 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
- Have positive anti-PLA2R autoantibody test results > 20 relative units (RU)/ml.
- During screening at least one testing of proteinuria must be >3.5 g/24h.
- Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.
Who cannot join
- Non-primary membranous nephropathy or other condition affecting the kidney.
- eGFR at screening < 45 mL/min/1.73m2 or kidney function not stable .
- Uncontrolled hypertension .
- Serum albumin level at screening # 25g/l.
- Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to >90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
- Acute or chronic infection,including positivity of tuberculosis infection test.
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- Positive serology for TP,HIV, HBV, or HCV.
- Lab testing abnormality as: WBC< 3000/mm³, Lymphocyte < 1000/ mm³, neutrophil <1500/mm³, Hb < 80g/L, Platelet count <100×10e9/ L, Prothrombin time>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin >1.5×ULN.
- Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia
Peking University First Hospital
Beijing
The Second Xiangya Hospital Of Central South University
Changsha, Changsha
Xiangya Third Hospital, Central South University
Changsha, Hunan
Sichuan Province People's Hospital
Chengdu, Sichuan
The First Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality
The Third Affiliated Hospital,Sun Yat Sen University
Guangzhou, Guangdong
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
The Second Affiliated Hospital of Harbin Medical University
Harbin, Harbin
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Zhongda Hospital Southeast University
Nanjing, Jiangsu
The first affliated hospital of NingBo university
Ningbo, Zhejiang
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Second Hospital of Shanxi Medical University
Shanxi, Taiyuan
Peking University Shenzhen Hospital
Shenzhen, Guangdong
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
The First Affiliated Hospital of Medical college of Xi'an Jiaotong University
Xian, Shanxi
About this study
Official title: A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases
EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases.
The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- EVER001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVER001Drug
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
EVER001Drug
A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases.
| Study group | Role | What they receive |
|---|---|---|
| EVER001 100mg | Experimental | EVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks. Receives: Drug: EVER001 |
| EVER001 200mg | Experimental | EVER001 200mg BID for 36 weeks. Receives: Drug: EVER001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Measured: 104 weeks.
clinical laboratory assessments.
Measured: 104 weeks.
vital signs.
Measured: 104 weeks.
physical examination
Measured: 104 weeks
ECG.
Measured: 104 weeks.
Secondary outcomes (6)
To evaluate whether EVER001 can modulate proteinuria in pMN.
Percentage change from baseline of 24 hr proteinuria throughout 52 weeks.
Measured: 52 weeks.
To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.
Percentage change from baseline of anti-PLA2R autoantibody level throughout 52 weeks.
Measured: 52 weeks.
To evaluate the clinical response and immunological response in pMN.
To evaluate the clinical response and immunological response in pMN.
Measured: 104 weeks.
Maximum Observed Plasma Concentration (Cmax) of EVER001
Measured: 52 weeks.
Minimum Observed Plasma Concentration (Cmin) of EVER001
Measured: 52 weeks.
Time to Reach Maximum Observed Concentration (Tmax) of EVER001.
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 posted6 Apr 2023
- Study start15 May 2023
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everest Medicines (China) Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800873
- Sponsor's protocol ID
- ES108001
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2023
- Last updated
- 15 Sep 2026
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases
- ClinicalTrials.gov ID
- NCT05800873
- Acronym / sponsor ID
- ES108001
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Everest Medicines (China) Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 6 Apr 2023 (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.
EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases.
The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVER001 100mg | Experimental | Drug: EVER001EVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks. |
| EVER001 200mg | Experimental | Drug: EVER001EVER001 200mg BID for 36 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
- Have positive anti-PLA2R autoantibody test results > 20 relative units (RU)/ml.
- During screening at least one testing of proteinuria must be >3.5 g/24h.
- Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.
Key exclusion criteria (9 listed)
- Non-primary membranous nephropathy or other condition affecting the kidney.
- eGFR at screening < 45 mL/min/1.73m2 or kidney function not stable .
- Uncontrolled hypertension .
- Serum albumin level at screening # 25g/l.
- Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to >90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
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 |
|---|---|---|
| EVER001A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases. | Drug | EVER001 100mg |
| EVER001A highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases. | Drug | EVER001 200mg |
Primary outcome
adverse events
Time frame: 104 weeks.
clinical laboratory assessments.
Time frame: 104 weeks.
vital signs.
Time frame: 104 weeks.
physical examination
Time frame: 104 weeks
ECG.
Time frame: 104 weeks.
6 secondary outcomes
To evaluate whether EVER001 can modulate proteinuria in pMN.
Time frame: 52 weeks.
To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.
Time frame: 52 weeks.
To evaluate the clinical response and immunological response in pMN.
Time frame: 104 weeks.
Maximum Observed Plasma Concentration (Cmax) of EVER001
Time frame: 52 weeks.
Minimum Observed Plasma Concentration (Cmin) of EVER001
Time frame: 52 weeks.
Time to Reach Maximum Observed Concentration (Tmax) of EVER001.
Time frame: 52 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVER001 in people with Primary Membranous Nephropathy, run by Everest Medicines (China) Co.,Ltd. at 19 sites 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 9 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: 104 weeks.). The study lists 5 primary outcomes in all. 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 15 Sep 2026.