Study of EVER001 Oral Treatment for Adults with Selected Proteinuric Kidney Diseases Including FSGS, MCD, and IgA Nephropathy

What this Trial Is About

Researchers are evaluating the investigational drug EVER001 in adults aged 18 to 75 years with primary Focal Segmental Glomerulosclerosis FSGS, Minimal Change Disease MCD, or IgA Nephropathy IgAN. This Phase 1b2 open-label study aims to assess the treatments potential effects and safety in these kidney disorders, focusing on proteinuric glomerular diseases. EVER001 targets multiple immune pathways but does not directly affect T cells or deplete B cells. The study will take place at about 30 centers in China, enrolling 45 participants divided equally among the three conditions. Participants will receive EVER001 as 100 mg oral capsules taken twice daily, totaling 200 mg per dose and four capsules daily, for a treatment duration of 52 weeks. This single-arm study evaluates the drugs efficacy and safety across the three conditions without a placebo or comparator group. The dosing schedule is consistent throughout the study period. During the study, participants will have assessments including laboratory safety tests, physical exams, chest X-rays, ECGs, and monitoring of vital signs such as blood pressure, pulse, and body temperature. Researchers will measure changes in urine protein-to-creatinine ratio, kidney function, serum albumin, and other clinical outcomes up to 56 weeks. Safety monitoring includes tracking adverse events, and participants will be followed closely throughout the treatment and observation period lasting up to 56 weeks.

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