EVER001 for Adults With Protein Leakage in Kidney Diseases
Tests EVER001 in adults with MCD, IgA nephropathy or FSGS kidney disease.
Plain-language title generated from the registry record
Registry title: Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
Key facts
- Where
- Beijing and Tianjin, ChinaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07614477, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Everest Medicines (China) Co.,Ltd.
- Trial code
- NCT07614477
- Record updated
- 5 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB; 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; At risk of bleeding; Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN; Hereditary or secondary FSGS/MCD; collapsing FSGS; BMI ≥ 35 kg/m² in participants with FSGS/MCD.