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Bruton's Tyrosine Kinase (BTK) Inhibitor

Zanubrutinib for Primary Membranous Nephropathy

Phase 2 & 3
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Biopsy-confirmed primary membranous nephropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5.5 years
Awards & highlights

Study Summary

This trial looks at how well a new drug, zanubrutinib, reduces protein in the urine of people with a kidney disease called membranous nephropathy.

Who is the study for?
This trial is for people with primary membranous nephropathy, confirmed by biopsy. They must have been treated with specific blood pressure medications (ACEI or ARB) for at least 24 weeks and have certain levels of protein in their urine. It's not open to those with secondary causes of the disease, active hepatitis B or C, severe liver issues, significant heart diseases, very low kidney function, a history of immune deficiency conditions like HIV or past spleen removals.Check my eligibility
What is being tested?
The study tests Zanubrutinib's ability to reduce protein in urine and compares its effectiveness against Tacrolimus in achieving complete remission. Participants are already on optimal supportive care and will be divided into two parts: one focusing on Zanubrutinib alone and the other comparing it directly with Tacrolimus.See study design
What are the potential side effects?
Potential side effects may include digestive disturbances, headaches, muscle pain, rash or bruising easily due to blood thinning effect; infections risk could increase as well since Zanubrutinib affects the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on the highest dose possible of ACEI or ARB for my condition for at least 24 weeks, with controlled blood pressure.
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My kidney disease was confirmed by a biopsy.
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My anti-PLA2R antibody levels are above 50 RU/mL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Change from Baseline in Urine Protein Creatinine Ratio (UPCR)
Part 2: Number of Participants Achieving Complete Remission
Secondary outcome measures
Number of Participants with ≥ 30% Estimated Glomerular Filtration Rate (eGFR) Reduction from Baseline
Part 1: Number Of Participants with Treatment-Emergent Adverse Events (TEAEs)
Part 1: Number of Participants with Complete Remission
+14 more

Side effects data

From 2024 Phase 3 trial • 652 Patients • NCT03734016
24%
Diarrhoea
20%
Hypertension
18%
Neutropenia
16%
COVID-19
16%
Arthralgia
15%
Anaemia
14%
Upper respiratory tract infection
13%
Muscle spasms
13%
Fatigue
12%
Rash
11%
Atrial fibrillation
10%
Pyrexia
10%
Thrombocytopenia
10%
Nausea
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Epistaxis
7%
Pain in extremity
7%
Peripheral swelling
7%
Constipation
7%
Oedema peripheral
7%
Back pain
7%
Dizziness
6%
Dyspepsia
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Hyperuricaemia
6%
Decreased appetite
6%
Bronchitis
5%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
5%
Petechiae
4%
Palpitations
4%
Blood pressure increased
4%
Dyspnoea
4%
Gastrooesophageal reflux disease
4%
COVID-19 pneumonia
4%
Cellulitis
4%
Haematuria
4%
Sinusitis
4%
Alanine aminotransferase increased
4%
Weight decreased
4%
Haematoma
4%
Oral herpes
4%
Myalgia
4%
Squamous cell carcinoma of skin
3%
Oropharyngeal pain
3%
Nasopharyngitis
3%
Gout
3%
Basal cell carcinoma
3%
Anxiety
3%
Paronychia
3%
Skin infection
3%
Paraesthesia
3%
Conjunctivitis
3%
Mouth ulceration
3%
Asthenia
3%
Pharyngitis
3%
Aspartate aminotransferase increased
3%
Productive cough
2%
Vertigo
2%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Pruritus
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Adenocarcinoma gastric
1%
Cerebral infarction
1%
Cardiac arrest
1%
Transient ischaemic attack
1%
Respiratory failure
1%
Syncope
1%
Lung adenocarcinoma
1%
Death
1%
Pleural effusion
1%
Abdominal pain upper
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
1%
Mastoiditis
1%
Pneumocystis jirovecii pneumonia
1%
Septic shock
1%
Haemolytic anaemia
1%
Subdural haematoma
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Myocardial infarction
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrutinib
Zanubrutinib

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Zanubrutinib Low DoseExperimental Treatment1 Intervention
Participants will receive Zanubrutinib once daily
Group II: Part 1 and Part 2: Zanubrutinib High doseExperimental Treatment1 Intervention
Participants will receive Zanubrutinib twice daily
Group III: TacrolimusActive Control1 Intervention
Participants will receive tacrolimus capsules for 64 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,532 Total Patients Enrolled

Media Library

Zanubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05707377 — Phase 2 & 3
Primary Membranous Nephropathy Research Study Groups: Part 1 and Part 2: Zanubrutinib High dose, Part 2: Zanubrutinib Low Dose, Tacrolimus
Primary Membranous Nephropathy Clinical Trial 2023: Zanubrutinib Highlights & Side Effects. Trial Name: NCT05707377 — Phase 2 & 3
Zanubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05707377 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled spots in this medical trial that participants may join?

"The clinical trial is currently in the process of aggregating participants, with a first post date of April 17th 2023 and an update to information occurring on May 30th."

Answered by AI

Is this trial accessible in multiple locations?

"This clinical trial is operational at 80 sites, comprising of Stanford University in Palo Alto, Northwestern University Feinberg School of Medicine in Chicago and Northshore University Healthsystem in Evanston. Additionally there are numerous other locations where the study can be accessed."

Answered by AI

Is it necessary for applicants to this research study be under 45 years of age?

"Elderly individuals over 18 years of age, but less than 75 years old, are eligible to participate in this project."

Answered by AI

How many participants are involved in this medical experiment?

"Affirmative, clinicaltrials.gov hosts data that confirms this experiment is currently selecting participants. Originally posted on April 17th 2023 and last updated May 30th 2023, the research team needs to recruit 282 individuals from 80 different sites."

Answered by AI

Is it possible for me to become part of this clinical investigation?

"This scientific endeavour is recruiting 282 individuals who are aged 18 to 75 and diagnosed with primary membranous nephropathy. Additional criteria include a UPCR (urine protein concentration ratio) > 3.5, treatment for at least 24 weeks with an ACEI or ARB prior to randomization 12 weeks before study drug administration in Part 1, and Anti-PLA2R antibody levels of over 50 RU/mL at the confirmation assessment (exclusive to Part 1)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy
2023. "A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05707377.
~188 spots leftby Dec 2028
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