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Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

RecruitingPhase 2Ages 18 Years - 75 YearsAllEverest Medicines (China) Co.,Ltd.
NCT07614477 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • EVER001
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Where

2 sites
Peking University First Hospital
Beijing, China
Tianjin Medical University General Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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