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NCT07614477
Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
Conditions: Minimal Change Disease (MCD), IgA Nephropathy (IgAN), Focal Segmental Glomerulosclerosis (FSGS)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 45
Sponsor: Everest Medicines (China) Co.,Ltd.
Location: Peking University First Hospital Beijing Beijing Municipality
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). 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.
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 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
Source: ClinicalTrials.gov (NCT07614477). StuddyBuddy aggregates publicly available trial information.