NCT07614477 Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases
| NCT ID | NCT07614477 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Everest Medicines (China) Co.,Ltd. |
| Condition | Minimal Change Disease (MCD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2026-05-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07614477 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Minimal Change Disease (MCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07614477 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07614477 currently recruiting?
Yes, NCT07614477 is actively recruiting participants. Contact the research team at fei.liao@everestmedicines.com for enrollment information.
Where is the NCT07614477 trial being conducted?
This trial is being conducted at Beijing, China, Tianjin, China.
Who is sponsoring the NCT07614477 clinical trial?
NCT07614477 is sponsored by Everest Medicines (China) Co.,Ltd.. The trial plans to enroll 45 participants.