NCT05707377

A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy

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: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Zanubrutinib capsules administered orally.
DRUG	Tacrolimus	Tacrolimus capsules administered orally.

Timeline

• Start date: 2023-04-17
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-01-31
• Last updated: 2026-03-05

Locations

48 sites across 9 countries: United States, Brazil, Canada, China, Czechia, Italy, Russia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study