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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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501147-32-00
Acronym
BGB-3111-309
Enrollment
32
Registered
2023-09-07
Start date
2024-07-11
Completion date
Unknown
Last updated
2025-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Membranous Nephropathy

Brief summary

Part 1: The primary endpoint is change from baseline in urine protein creatinine ratio (UPCR) at Week 24., Part 2: The primary endpoint is complete remission status (Yes/No) (for definition of complete remission, refer to Section 8.2.1 of the protocol) at Week 104.

Detailed description

Part 1: Treatment failure status (Yes/No) by Week 24, Part 1: Immunological response status (Yes/No) at Week 24, Part 1: Complete remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Overall remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Relapse status (Yes/No) by Week 104, Part 1: Incidence and severity of treatment-emergent adverse events, Part 2: overall remission status (Yes/No) (for definition of overall remission, refer to Section 8.2.3 of the protocol) at Week 104., Part 2: Complete remission status (Yes/No) at Week 24, Week 52, and Week 76, Part 2: Overall remission status (Yes/No) at Week24, Week 52, and Week 76, Part 2: Treatment failure status (Yes/No) by Week 24, Week 52, Week 76, and Week 104, Part 2: Time to first complete remission: the time from the date of randomization to the date of the first complete remission, Part 2: Time to first overall remission: the time from the date of randomization to the date of the first overall remission, Part 2: Relapse status (Yes/No) by Week 104, Part 2: Time to first relapse: the time from the date of first complete or partial remission to the date of the first relapse, Part 2: Patient-reported symptoms and overall health status as measured using the Kidney Disease and Quality of Life instrument™ - 36 items (KDQoL-36) and European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D- 5L), Part 2: ≥ 30% eGFR reduction from baseline to Week 52 and Week 104 (Yes/No), Part 2: Incidence and severity of treatment-emergent adverse events

Interventions

DRUGTACROLIMUS
DRUGZanubrutinib

Sponsors

BeOne Medicines AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: The primary endpoint is change from baseline in urine protein creatinine ratio (UPCR) at Week 24., Part 2: The primary endpoint is complete remission status (Yes/No) (for definition of complete remission, refer to Section 8.2.1 of the protocol) at Week 104.

Secondary

MeasureTime frame
Part 1: Treatment failure status (Yes/No) by Week 24, Part 1: Immunological response status (Yes/No) at Week 24, Part 1: Complete remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Overall remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Relapse status (Yes/No) by Week 104, Part 1: Incidence and severity of treatment-emergent adverse events, Part 2: overall remission status (Yes/No) (for definition of overall remission, refer to Section 8.2.3 of the protocol) at Week 104., Part 2: Complete remission status (Yes/No) at Week 24, Week 52, and Week 76, Part 2: Overall remission status (Yes/No) at Week24, Week 52, and Week 76, Part 2: Treatment failure status (Yes/No) by Week 24, Week 52, Week 76, and Week 104, Part 2: Time to first complete remission: the time from the date of randomization to the date of the first complete remission, Part 2: Time to first overall remission: the time from the date of randomization to the date of the f

Countries

Czechia, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026