A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy (NCT05707377)
A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy
🩺 Plain-English Summary (8th-Grade Level)
The primary objectives of this study are: In Part 1 to evaluate the efficacy of zanubrutinib as measured by proteinuria reduction, and in Part 2 to evaluate the efficacy of zanubrutinib compared with tacrolimus as measured by complete remission rate, in participants with primary membranous nephropathy (PMN) who are on optimal supportive care.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).
Location: Amicis Research Center — Granada Hills, California
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants with a secondary cause of membranous nephropathy
- Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
- Severe renal disease as determined by rapid decline in eGFR (defined as \> 15 mL/min/1.73m\^2 within 24 weeks prior to randomization, not otherwise explained)
- A known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infections
- Patients at risk for tuberculosis at screening
- Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody
- Severe hepatic insufficiency (Child-Pugh C)
- Clinically significant cardio-cerebrovascular diseases Note: Other protocol defined Inclusion/Exclusion criteria may apply.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (47 Sites)
Showing the first 25 of 47 sites.
- Amicis Research Center — Granada Hills, California
- Stanford University — Palo Alto, California
- Intermed Consultants — Minneapolis, Minnesota
- Kidney Specialist of Southern Nevada (Ksosn) — Las Vegas, Nevada
- University of Cincinnati College of Medicine — Cincinnati, Ohio
- Carolina Nephrology — Spartanburg, South Carolina
- Instituto Pro Renal Brasil — Curitiba,
- Ott Healthcare, Inc (Corporate Medical Centre) — Scarborough Village, Ontario
- Beijing An Zhen Hospital, Capital Medical University — Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality
- Fujian Medical University Union Hospital — Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian
- Guangdong Provincial Peoples Hospital — Guangzhou, Guangdong
- The First Affiliated Hospital, Sun Yat Sen University — Guangzhou, Guangdong
- Peking University Shenzhen Hospital — Shenzhen, Guangdong
- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi
- Guizhou Provincial Peoples Hospital — Guiyang, Guizhou
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei
- The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang
- Nanyang Central Hospital — Nanyang, Henan
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei
- Renmin Hospital of Wuhan University — Wuhan, Hubei
- The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Primary Membranous Nephropathy
- Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN) — Montgomery, Alabama
- Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) — Loma Linda, California
- A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN) — Huntsville, Alabama
- A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy — Denver, Colorado
- A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy — San Francisco, California
Explore by condition: All Primary Membranous Nephropathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.