Everest001: a medicine for certain kidney diseases to see if it helps adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b/2 open-label, multicenter trial conducted in China at ~30 centers, enrolling 45 adults aged 18-75 with selected proteinuric glomerular diseases. Participants will receive EVER001 as a 100 mg oral capsule, dosed as 200 mg twice daily for 52 weeks, and will be followed for safety, pharmacokinetics, and pharmacodynamics alongside clinical outcomes. The study focuses on non-immunosuppressant pathways to modulate immune activity without depleting T or B lymphocytes. Inclusion requires biopsy-confirmed disease, adequate kidney function, and proteinuria thresholds specific to each condition; several exclusions apply, including active infections and certain comorbidities. Lead sponsor is Everest Medicines (China) Co., Ltd., with participating sites at Peking University First Hospital and Tianjin Medical University General Hospital.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Tianjin Medical University General Hospital
  Tianjin, Hebei, China Recruiting

Study contacts

• Study coordinator: Everest Clinical Trial Information Center
• Email: ctinfo.center@everestmedicines.com
• Phone: +86 21 8012 5712

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.