Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

Launched by EVEREST MEDICINES (CHINA) CO.,LTD. · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called EVER001, which is an oral treatment designed to help people with a kidney condition known as primary membranous nephropathy. This condition causes a high level of protein in the urine, which can lead to kidney damage. The researchers want to find out how well EVER001 works, how safe it is, and how it behaves in the body. The trial is currently looking for participants who are between 65 and 93 years old and have a confirmed diagnosis of primary membranous nephropathy with specific test results showing high protein levels in their urine.

To be eligible for the trial, participants must have had this kidney condition for at least 8 weeks without improvement, despite receiving standard treatments. However, some people might not qualify if they have other kidney conditions, unstable kidney function, or have recently taken certain medications. Participants in the trial will have regular check-ups and tests to monitor their health and how the medication affects them. This study aims to help improve treatment options for people suffering from this kidney disease, so if you or a loved one are facing these health challenges, this trial might be an important opportunity to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
• • 2. Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
• • 3. During screening at least one testing of proteinuria must be \>3.5 g/24h.
• • 4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.
• Exclusion Criteria:
• • 1. Non-primary membranous nephropathy or other condition affecting the kidney.
• • 2. eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
• • 3. Uncontrolled hypertension .
• • 4. Serum albumin level at screening # 25g/l.
• • 5. Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to \>90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
• • 6. Acute or chronic infection,including positivity of tuberculosis infection test.
• • 7. Positive serology for TP,HIV, HBV, or HCV.
• • 8. Lab testing abnormality as: WBC\< 3000/mm³, Lymphocyte \< 1000/ mm³, neutrophil \<1500/mm³, Hb \< 80g/L, Platelet count \<100×10e9/ L, Prothrombin time\>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin \>1.5×ULN.
• • 9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.