No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Everest Medicines (China) Co.,Ltd. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 in…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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 gro…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.