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Tests treatment safety and results for Primary Membranous Nephropathy
Official title Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001
ClinicalTrials.gov ID: NCT05800873
What this study is testing
What is EVER001?
EVER001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary membranous nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases. The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
- Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
- During screening at least one testing of proteinuria must be \>3.5 g/24h.
- Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\<50% reduction) despite supportive therapy of ACE inhibitor...
You likely can't join if
- Non-primary membranous nephropathy or other condition affecting the kidney.
- eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
- Uncontrolled hypertension .
- Serum albumin level at screening # 25g/l.
- Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab...
- Acute or chronic infection,including positivity of tuberculosis infection test.
See the full eligibility criteria
- Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
- Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
- During screening at least one testing of proteinuria must be \>3.5 g/24h.
- 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...
- Non-primary membranous nephropathy or other condition affecting the kidney.
- eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
- Uncontrolled hypertension .
- Serum albumin level at screening # 25g/l.
- 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...
- Acute or chronic infection,including positivity of tuberculosis infection test.
- Positive serology for TP,HIV, HBV, or HCV.
- Lab testing abnormality as: WBC\ 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.
- Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Changsha, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Harbin, Harbin, China
- Changsha, Hunan, China
- Baotou, Inner Mongolia, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Shanxi, Taiyuan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Taizhou, Zhejiang, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Changsha, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Harbin, Harbin, China; Changsha, Hunan, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.