Minimal Change Disease (MCD)Phase 2NCT07614477
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
A Phase 2 study testing EVER001 in people with Minimal Change Disease (MCD) and IgA Nephropathy (IgAN), run by Everest Medicines (China) Co.,Ltd. at 2 sites in China.
Trial summary
This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Minimal Change Disease (MCD), IgA Nephropathy (IgAN), Focal Segmental Glomerulosclerosis (FSGS)
- 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
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 20 May 2026to 31 Mar 2029
- Phase
- Phase 2
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
- Primary FSGS or MCD/IgAN confirmed by renal biopsy
- eGFR ≥ 45 mL/min/1.73 m²
- For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) > 3.5 g/g and serum albumin < 30 g/L during the screening period
- For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
- Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment
Who cannot join
- Hereditary or secondary FSGS/MCD; collapsing FSGS
- BMI ≥ 35 kg/m² in participants with FSGS/MCD
- Evidence of diabetes mellitus or a history of diabetes mellitus
- Acute or chronic infection requiring treatment
- Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
- Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
- At risk of bleeding
- Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100730
Hong Zhang, +8610-83575530, hongzh@bjmu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Hebei
yan jun Jia, +86-13821735536, jiajunya@126.com
About this study
Official title: The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)
This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at ~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.
- Conditions
- Minimal Change Disease (MCD), IgA Nephropathy (IgAN), Focal Segmental Glomerulosclerosis (FSGS)
- Being tested
- EVER001
- Medical subject headings
- Nephrosis, Lipoid, Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVER001Drug
EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA
| Study group | Role | What they receive |
|---|---|---|
| EVER001 200mg bid | Experimental | Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA Receives: Drug: EVER001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)
Measured: Week24
Treatment-emergent adverse events (TEAEs)
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)
Measured: Throughout the study period, up to Week 56
Adverse events of special interest (AESIs)
Incidence of adverse events of special interest (AESIs)
Measured: Throughout the study period, up to Week 56
Systolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Measured: Throughout the study period, up to Week 56
Body weight change from baseline
Measured in kilograms (kg) using a calibrated clinical scale
Measured: Throughout the study period, up to Week 56
Change from baseline in clinical laboratory safety parameters
Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units
Measured: Throughout the study period, up to Week 56
Physical examination findings
Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.
Measured: Throughout the study period, up to Week 56
Chest radiography findings
Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.
Measured: Throughout the study period, up to Week 56
12-lead electrocardiogram (ECG) findings
Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.
Measured: Throughout the study period, up to Week 56
Pulse rate change from baseline
Measured in beats per minute (bpm) using a calibrated vital signs monitor
Measured: Throughout the study period, up to Week 56
Diastolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Measured: Throughout the study period, up to Week 56
Body temperature change from baseline
Measured in degrees Celsius (°C) using a calibrated clinical thermometer
Measured: Throughout the study period, up to Week 56
Secondary outcomes (20)
Percentage change from baseline in 24-hour UPCR
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Measured: Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR)
Proportion of participants achieving complete remission (CR) based on predefined criteria
Measured: Week 2 and thereafter, up to Week 56
Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline
Proportion of participants with IgAN achieving ≥30% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, assessed at Week 24, Week 36, and Week 52
Measured: At Week 24, Week 36, and Week 52
Change from baseline in estimated glomerular filtration rate (eGFR)
Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol
Measured: Week 2 and thereafter, up to Week 56
eGFR slope from baseline
Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52
Measured: Baseline to Week 52
Percentage change from baseline in serum albumin
Percentage change from baseline in serum albumin level
Measured: Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR)
Proportion of participants achieving partial remission (PR) based on predefined study criteria
Measured: Week 2 and thereafter, up to Week 56
Proportion of participants achieving CR or PR
Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria
Measured: Week 2 and thereafter, up to Week 56
Time to achieve CR or PR
Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria
Measured: Baseline to Week 52
Proportion of participants with relapse (CR/PR, no rescue therapy)
Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy
Measured: From Day1 to Week 52
Time from CR/PR to relapse
Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse
Measured: From Day1 to Week 52
Cumulative dose of glucocorticoids (GC)
Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits
Measured: Week 16, Week 24, Week 32, Week 40, and Week 52
Proportion requiring GC increase or additional immunosuppressants
Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants
Measured: Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria
Proportion of participants with IgAN with positive hematuria
Measured: At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants
Resolution of hematuria in participants with IgA
Measured: At Week 12, Week 24, Week 36, and Week 52
Change from baseline in BTK target occupancy
Change from baseline in BTK target occupancy in peripheral blood cells
Measured: Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
Plasma EVER001 peak concentration (Cmax)
Measured: Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001
Plasma EVER001 trough concentration (Cmin)
Measured: Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00
Time to reach peak concentration (Tmax) of EVER001
Measured: Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001
Accumulation ratio (AR) of EVER001
Measured: Throughout the study period, up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start20 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Change Disease (MCD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
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
- NCT07614477
- Sponsor's protocol ID
- ES108001-001
- Other IDs
- CTR20260886
- Status last verified
- Apr 2026
- First submitted
- 5 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No