A Phase 2 interventional study of EVER001 in Minimal Change Disease (MCD), IgA Nephropathy (IgAN) and Focal Segmental Glomerulosclerosis (FSGS), sponsored by Everest Medicines (China) Co.,Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Everest Medicines (China) Co.,Ltd. · Phase 2, Interventional, and Treatment
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.
75 studies on the registry are indexed under Nephrosis, Lipoid; 32 are open to participants now.
This study's planned enrollment of 45 is close to the median of 49 across 46 interventional studies indexed under Nephrosis, Lipoid.
Browse Nephrosis, Lipoid studies →Everest Medicines (China) Co.,Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: EVER001
EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA
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)
Time frame: Week24
Treatment-emergent adverse events (TEAEs)
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)
Time frame: Throughout the study period, up to Week 56
Adverse events of special interest (AESIs)
Incidence of adverse events of special interest (AESIs)
Time frame: Throughout the study period, up to Week 56
Systolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Time frame: Throughout the study period, up to Week 56
Body weight change from baseline
Measured in kilograms (kg) using a calibrated clinical scale
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Throughout the study period, up to Week 56
Diastolic blood pressure change from baseline
Measured in mmHg using a calibrated clinical blood pressure monitor
Time frame: Throughout the study period, up to Week 56
Body temperature change from baseline
Measured in degrees Celsius (°C) using a calibrated clinical thermometer
Time frame: Throughout the study period, up to Week 56
Percentage change from baseline in 24-hour UPCR
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 52
Percentage change from baseline in serum albumin
Percentage change from baseline in serum albumin level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria
Proportion of participants with IgAN with positive hematuria
Time frame: At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants
Resolution of hematuria in participants with IgA
Time frame: 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
Time frame: Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
Plasma EVER001 peak concentration (Cmax)
Time frame: Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001
Plasma EVER001 trough concentration (Cmin)
Time frame: Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00
Time to reach peak concentration (Tmax) of EVER001
Time frame: Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001
Accumulation ratio (AR) of EVER001
Time frame: Throughout the study period, up to Week 56
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2028, 31 months after the start.
How these figures are worked out, and which studies are left out of them.
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Everest Medicines (China) Co.,Ltd.