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

Study acronym: ALMOND

StatusActive, Not Recruiting

PhasePhase 2/3

SponsorBeOne Medicines

Started2023-04-17

View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-09

Study Status, Contacts/Locations v50

Study sites47→45

2026-07-22

Study Status, Contacts/Locations v49

Study sites48→47

2026-06-01

Study Status, Contacts/Locations v48

Study sitesdetails revised at 1 of 48 sites

2026-03-04

Study Status, Contacts/Locations v47

Study sites49→48

2026-02-20

Study Status, Contacts/Locations v46

Study sites51→49

Show 45 earlier versions

2026-01-21

Study Status, Study Description, Contacts/Locations v45

Study sites53→51

Study description+209 characters

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.

2025-12-22

Study Status, Contacts/Locations v44

Study sites58→53

2025-12-15

Study Status, Contacts/Locations v43

Study sites58 entries, revised

~~Zigong First Peoples Hospital, Zigong Academy~~University of ~~Medical~~Cincinnati ~~Sciences~~College of Medicine

2025-11-19

Study Status, Contacts/Locations v42

Study sites61→58

2025-11-06

Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v41

Trial statusRecruiting→Active, Not Recruiting

Primary completion date2028-04→2027-10

Completion date2028-04→2027-10

Enrollment targetestimated 282→confirmed 178

Study sites64→61

2025-10-23

Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v40

Study sites69→64

Lead sponsorBeiGene→BeOne Medicines

2025-09-19

Study Status, Contacts/Locations v39

Study sitesdetails revised at 10 of 69 sites

2025-09-11

Study Status, Contacts/Locations v38

Study sitesdetails revised at 1 of 69 sites

2025-08-05

Study Status, Contacts/Locations v37

Study sites69 entries, revised

Centro de Investigaciones ~~Madicas~~Medicas Mar Del Plata

2025-07-22

Study Status, Contacts/Locations v36

Study sites71→69

2025-07-10

Study Status, Contacts/Locations v35

Study sitesdetails revised at 1 of 71 sites

2025-06-23

Study Status, Contacts/Locations v34

Study sites71 entries, revised

~~Prolato~~Medical ~~Clinical~~Company ~~Research Center~~Llc

2025-06-04

Study Status, Contacts/Locations v33

Study sitesdetails revised at 14 of 71 sites

2025-05-07

Study Status, Contacts/Locations v32

Study sitesdetails revised at 4 of 71 sites

2025-04-10

Study Status, Contacts/Locations v31

Study sites77→71

2025-03-21

Study Status, Contacts/Locations v30

Study sites75→77

2025-03-07

Study Status, Contacts/Locations v29

Study sites72→75

2025-02-14

Study Status, Contacts/Locations, IPDSharing v28

Study sites80→72

2025-01-28

Study Status, Contacts/Locations v27

Study sites80 entries, revised

~~Uniwersytecki~~San ~~Szpital~~Antonio ~~Kliniczny~~Kidney ImDisease ~~Jana~~Center ~~Mikulicza~~Physicians ~~Radeckiego~~Group, WePllc ~~Wroclawiu~~Medical Center

2025-01-16

Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v26

Primary completion date2028-12→2028-04

Completion date2028-12→2028-04

Study sites74→80

Study arms3→4

InterventionsTacrolimus (Drug), Zanubrutinib (Drug), Zanubrutinib (Drug)→Tacrolimus (Drug), Zanubrutinib (Drug)

Eligibility criteria+301 characters

Inclusion Criteria: Biopsy-confirmed ~~primary membranous nephropathy~~PMN within 5 years before the initial screening (ie, the day th [...] on 24-hour urine collection) > 3.5 at initial screening and at confirmation assessment Treatment with a maximally tolerated [...] dy drug for Part 1) and with adequate blood pressure control (blood pressure < 130/80 mmHg, measured on ≥ 2 occasions [not on the same day] within 4 weeks before the assignment of study treatment) Anti-PLA2R antibody > 50 RU/mL at confirmation assessment ( [...] etes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening Severe renal disease as determi [...] [...]

Secondary endpointsdetails revised at 11 of 17 entries

Study title-1 characters

A Study to ~~Evaluate~~Examine the ~~Safety~~Efficacy and ~~Efficacy~~Safety of Zanubrutinib inGiven ~~Participants~~to Adults With Primary Membranous Nephropathy

2024-12-04

Study Status, Contacts/Locations v25

Study sites32→74

2024-10-25

Study Status, Contacts/Locations v24

Study sites69→32

2024-10-17

Study Status, Contacts/Locations v23

Study sites66→69

2024-09-27

Study Status, Contacts/Locations v22

Study sites65→66

2024-08-27

Study Status, Contacts/Locations v21

Study sites64→65

2024-08-19

Study Status, Contacts/Locations v20

Study sites57→64

2024-07-30

Study Status, Contacts/Locations v19

Study sites51→57

2024-07-16

Study Status, Contacts/Locations v18

Study sites49→51

2024-07-08

Study Status, Contacts/Locations v17

Study sites46→49

2024-06-05

Study Status, Contacts/Locations v16

Study sites45→46

2024-04-23

Study Status, Contacts/Locations v15

Study sites43→45

2024-03-18

Study Identification, Study Status, Outcome Measures, Eligibility v14

Eligibility criteria+45 characters

Inclusion Criteria: Biopsy-confirmed primary membranous nephropathy within 5 years before the initial screening (ie, the day the informed consent is signed) UPCR (based on 24-hour urine collection) > 3.5 at initial s [...] etes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening ~~The eGFR < 40 mL/min/1.73 m2, or initiation of dialysis~~ A known history of a primary immunodeficiency or an underlyi [...] splenectomy that predisposes the participant to infections ~~Positive~~Patients at risk for tuberculosis at screening Known infection with serologic st [...]

Secondary endpoints17 entries, revised

Part 2: Health Related quality of Life (HRQoL) t Using the Kidney Disease and Quality of Life instrument™ - 36 items (KDQoL-36) Number of Participants with ≥ 30% ~~ReceptorEstimated~~Estimated Glomerular Filtration Rate (eGFR) Reduction from Baseline

Primary endpoints2 entries, revised

Part 1: ~~Reduction~~Change from Baseline in Urine Protein Creatinine Ratio (UPCR)

2024-01-11

Study Status, Contacts/Locations v13

Study sites42→43

2024-01-04

Study Status, Contacts/Locations v12

Study sites39→42

2023-12-01

Study Identification, Study Status, Contacts/Locations v11

Study sites38→39

2023-11-08

Study Status, Contacts/Locations v10

Study sites37→38

2023-10-25

Study Status, Contacts/Locations v9

Study sites34→37

2023-09-26

Study Status, Contacts/Locations v8

Study sites33→34

2023-09-15

Study Status, Contacts/Locations v7

Study sites29→33

2023-08-24

Study Status, Contacts/Locations v6

Study sites26→29

2023-08-10

Study Status, Contacts/Locations v5

Study sites23→26

2023-07-26

Study Status, Contacts/Locations v4

Study sites22→23

2023-07-21

Study Status, Contacts/Locations v3

Study sites80→22

2023-05-30

Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v2

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2023-04→confirmed 2023-04-17

Study sites0→80

Secondary endpoints17 entries, revised

Part 2: Health Related quality of Life (HRQoL) het Using the Kidney Disease and Quality of Life instrument™ - 36 items (KDQoL-36) Number of Participants with ≥ 30% ~~Epidermal~~ReceptorEstimated ~~Growth~~Glomerular ~~Factor~~Filtration ~~Receptor~~Rate (eGFR) Reduction from Baseline

2023-02-20

Study Status, Eligibility v1

Eligibility criteriarevised

[...] t confirmation assessment (Part 1 only) Exclusion Criteria: ⇅ moved Participants with a secondary cause of membranous nephropathy Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ [...]

BeOne Medicines

59 trials monitored

See 7 trials at risk

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.

Trial Details

NCT Number	NCT05707377
Lead Sponsor	BeOne Medicines
Conditions	Primary Membranous Nephropathy
Enrollment	178 participants
Start Date	2023-04-17
Primary Completion	2027-10 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-09-11