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Active, Not Recruiting

NCT Number: NCT05707377

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Membranous Nephropathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Instituto Pro Renal Brasil, Curitiba, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-confirmed PMN 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 screening and at confirmation assessment
  • Treatment with a maximally tolerated or allowed dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for ≥ 24 weeks before randomization (12 weeks before initiation of study 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 (Part 1 only)

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.

Treatment and study plan

Zanubrutinib

Drug

Zanubrutinib capsules administered orally.

Other names: BGB-3111, Brukinsa

Tacrolimus

Drug

Tacrolimus capsules administered orally.

Primary outcomes

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

    Time frame: Baseline and Week 24

  2. Part 2: Number of Participants Achieving Complete Remission

    Time frame: Week 104

    Complete remission is defined as:

    UPCR (based on 24-hour urine collection) ≤ 0.3, AND a stable estimated glomerular filtration rate (eGFR) (remains unchanged or decreases by < 15% compared with the baseline)

Secondary outcomes

  1. Part 1: Number of participants with Treatment Failure

    Time frame: Week 24

  2. Part 1: Number of Participants with Immunological Response

    Time frame: Week 24

    Immunological response is defined as anti- phospholipase A2 receptor (PLA2R) antibody level reduced from baseline to less than 14 relative units (RU)/ml.

  3. Part 1: Number of Participants with Complete Remission

    Time frame: Week 24, Week 52, Week 76, and Week 104

    A complete remission is defined as:

    UPCR (based on 24-hour urine collection) ≤ 0.3, AND a stable eGFR (remains unchanged or decreases by < 15% compared with the baseline)

  4. Part 1: Number of Participants with Overall Remission

    Time frame: Week 24, Week 52, Week 76, and Week 104

    Participants with overall remission are those achieving either complete remission or partial remission

  5. Part 1: Number of Participants with Relapse

    Time frame: Week 104

    A relapse is defined as reappearance of UPCR (based on 24-hour urine collection) > 3.5 after complete or partial remission

  6. Part 1: Number Of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the first dose of study drug and up to 30 days after study drug discontinuation; up to approximately 68 weeks

  7. Part 2: Number of Participants with Overall Remission

    Time frame: Week 24, Week 52, Week 76, and Week 104

    Participants with overall remission are those achieving either complete remission or partial remission

  8. Part 2: Number of Participants with Complete Remission

    Time frame: Week 24, Week 52, and Week 76

    A complete remission is defined as:

    UPCR (based on 24-hour urine collection) ≤ 0.3, AND a stable eGFR (remains unchanged or decreases by < 15% compared with the baseline)

  9. Part 2: Number of participants with Treatment Failure

    Time frame: Week 24, Week 52, Week 76, and Week 104

  10. Part 2: Time to First Complete Remission

    Time frame: Up to approximately 104 weeks

    Time to First Complete Remission is the time from the date of randomization to the date of the first complete remission

  11. Part 2: Time to First Overall Remission

    Time frame: Up to approximately 104 weeks

    Time to first overall remission is the time from the date of randomization to the date of the first overall remission

  12. Part 2: Number of Participants with Relapse

    Time frame: Week 104

    A relapse is defined as reappearance of UPCR (based on 24-hour urine collection) > 3.5 after complete or partial remission

  13. Part 2: Time to First Relapse

    Time frame: Up to approximately 104 weeks

    Time to first relapse is the time from the date of first complete or partial remission to the date of the first relapse

  14. Part 2: Health Related quality of Life (HRQoL) Using the Kidney Disease and Quality of Life instrument™ - 36 items (KDQoL-36)

    Time frame: Up to approximately 104 weeks

  15. Part 2: Health Related quality of Life (HRQoL) Using European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L)

    Time frame: Up to approximately 104 weeks

  16. Number of Participants with ≥ 30% Estimated Glomerular Filtration Rate (eGFR) Reduction from Baseline

    Time frame: Baseline, Week 52, and Week 104

  17. Part 2: Number of Participants with TEAEs

    Time frame: From the first dose of study drug and up to 30 days after study drug discontinuation; up to approximately 68 weeks

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

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

Acronym: ALMOND

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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