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Can a pill calm the immune attack on kidneys?

NCT ID NCT05800873

Disease control Sponsor: Everest Medicines (China) Co.,Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This trial tests an experimental oral drug called EVER001 in people with primary membranous nephropathy, a kidney disease where the immune system damages the kidney's filtering units, causing protein to leak into urine. The study aims to see if EVER001 can reduce proteinuria and lower harmful autoantibodies, potentially slowing disease progression. About 31 participants with biopsy-confirmed disease and high protein levels will receive the drug, with safety and effectiveness monitored over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EVER001, an oral BTK inhibitor
What this could lead to
If successful, EVER001 could offer a new oral treatment option to reduce proteinuria and potentially slow kidney damage in people with primary membranous nephropathy.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Possible side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

May 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary membranous nephropathy

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Second Hospital of Shanxi Medical University

    Shanxi, Taiyuan, China

  • Sichuan Province People's Hospital

    Chengdu, Sichuan, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, China

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, China

  • The First Affiliated Hospital of Medical college of Xi'an Jiaotong University

    Xian, Shanxi, China

  • The First Affiliated Hospital of PLA Army Medical University

    Chongqing, Chongqing Municipality, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Harbin, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Xiangya Hospital Of Central South University

    Changsha, Changsha, China

  • The Third Affiliated Hospital,Sun Yat Sen University

    Guangzhou, Guangdong, China

  • The first affliated hospital of NingBo university

    Ningbo, Zhejiang, China

  • Xiangya Third Hospital, Central South University

    Changsha, Hunan, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, China

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