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Zanubrutinib in Primary Membranous Nephropathy
NCT05707377Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2023
- Primary completion
- Oct 2027
- Countries
- 9
- Sponsor
- BeOne Medicines
- Modality
- Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders
- Drugs
- zanubrutinib
- Conditions
- primary membranous nephropathy (PMN)
01
Overview
Phase 3, randomised, open-label trial of zanubrutinib in primary membranous nephropathy (PMN) (4 arms), sponsored by BeOne Medicines. Primary endpoints: Urine Protein Creatinine Ratio at 24 weeks and Complete Remission at 104 weeks. Started Apr 2023; status: active, not recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
Part 1: Zanubrutinib High Dose
Participants will receive zanubrutinib twice daily.
Part 2: Zanubrutinib High Dose
Participants will receive zanubrutinib twice daily.
Part 2: Zanubrutinib Low Dose
Participants will receive zanubrutinib once daily.
Part 2: Tacrolimus
Participants will receive tacrolimus capsules twice daily for 64 weeks.
03
Who it enrols
Patients with biopsy-confirmed primary membranous nephropathy within 5 years, UPCR > 3.5, on stable ACEI/ARB therapy with controlled blood pressure. Excludes secondary membranous nephropathy, poorly controlled diabetes, severe renal disease with rapid eGFR decline, immunodeficiency, active infections (HIV, HBV, HCV), severe hepatic insufficiency, and significant cardio-cerebrovascular diseases.
04
Endpoints
Primary
Urine Protein Creatinine Ratio
Complete Remission
Secondary
Treatment Failure
Immunological Response
Complete Remission
Overall Remission
Relapse
Treatment-Emergent Adverse Events
Time to First Complete Remission
Time to First Overall Remission
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