Not recruitingRare disease

Study of Zanubrutinib and Tacrolimus for Patients with Primary Membranous Nephropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a kidney condition called Primary Membranous Nephropathy. This condition affects the filtering units of the kidneys, leading to protein loss in the urine. The study will compare the effectiveness and safety of two medications: Zanubrutinib and Tacrolimus. Zanubrutinib, also known by its code name BGB-3111, is a medication that may help reduce protein loss in the urine. Tacrolimus is another medication that is commonly used to suppress the immune system and is being used as a comparison in this study.

The purpose of the study is to evaluate how well Zanubrutinib works in reducing protein in the urine and achieving complete remission, which means the disease is no longer active. The study will be conducted in two parts. In the first part, participants will receive Zanubrutinib to see how it affects protein levels in the urine. In the second part, participants will be randomly assigned to receive either Zanubrutinib or Tacrolimus to compare their effectiveness in achieving complete remission.

Participants will take the medications in capsule form by mouth. The study will last for a period of up to 64 weeks, during which time participants will have regular check-ups to monitor their health and the effects of the medication. The study aims to provide valuable information on the potential benefits of Zanubrutinib for people with Primary Membranous Nephropathy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide written consent to participate.
Eligibility criteria include being between 18 to 75 years old, having a confirmed diagnosis of primary membranous nephropathy, and meeting specific health conditions.
Step 2
Part 1: initial treatment phase
The patient will receive zanubrutinib in capsule form, taken orally. The dosage and frequency will be determined by the study protocol.
The primary goal is to evaluate the reduction in protein levels in urine over 24 weeks.
Step 3
Part 1: monitoring and assessments
Regular assessments will be conducted to monitor the patient's health and response to the treatment. This includes measuring urine protein levels and checking for any adverse effects.
The patient's blood pressure and other health indicators will be monitored to ensure safety and effectiveness.
Step 4
Part 2: comparison phase
In this phase, the patient may be randomly assigned to receive either zanubrutinib or tacrolimus, both administered orally in capsule form.
The aim is to compare the effectiveness of the two medications in achieving complete remission over a period of 104 weeks.
Step 5
Part 2: ongoing monitoring
The patient will continue to undergo regular health assessments, including urine tests and monitoring for any side effects.
The study will track the time to first remission and any potential relapses.
Step 6
End of study
The study is expected to conclude by May 2028. At the end of the study, the patient's overall health and treatment outcomes will be evaluated.
The patient will receive information about the study's findings and any implications for their future care.

Who can join the trial?

8 criteria

Must be between 18 to 75 years old on the day of signing the consent form.
Must be able to provide written consent, either by themselves or through a legally acceptable representative, and agree to follow the study requirements.
Must have a confirmed diagnosis of primary membranous nephropathy through a biopsy within the last 5 years.
Must have a UPCR (a measure of protein in urine) greater than 3.5, based on a 24-hour urine collection, at the initial screening and confirmation assessment.
Female patients who can have children must use highly effective birth control methods from the day of signing the consent form, throughout the study, and for at least 30 days after the last dose of the study drug. Male patients must either abstain from heterosexual intercourse, have had a vasectomy, or agree to use barrier contraception along with other methods during the study and for at least 30 days after the last dose of the study drug.
For Part 1 only: Must have been treated with the highest tolerated or allowed dose of ACEI or ARB (medications for blood pressure) for at least 12 weeks before the first dose of the study drug, with blood pressure under control (less than 130/80 mmHg) on at least two occasions within 4 weeks before starting the study treatment.
For Part 1 only: Must have an anti-PLA2R antibody level greater than 50 RU/mL at the confirmation assessment. Anti-PLA2R antibodies are proteins in the blood that can be associated with kidney disease.
For Part 2 only: Must have been treated with the highest tolerated or allowed dose of ACEI or ARB for at least 24 weeks before randomization, with blood pressure under control (less than 130/80 mmHg) on at least two occasions within 4 weeks before randomization.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that requires treatment.
Patients who have a history of cancer, except for certain types of skin cancer.
Patients who are currently using other medications that could affect the study results.
Patients who have a known allergy to the study medication or similar drugs.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a history of drug or alcohol abuse.
Patients who have a condition that affects their immune system.
Patients who have had a kidney transplant.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Verified
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
Pavia, Italy
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland

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Investigated drugs

Zanubrutinib
is a medication being studied for its ability to reduce proteinuria, which is the presence of excess proteins in the urine, in patients with primary membranous nephropathy. This condition affects the kidneys, and the study aims to see how well zanubrutinib can help manage this by improving kidney function.
Tacrolimus
is another medication used in the study to compare its effectiveness against zanubrutinib. Tacrolimus is commonly used to suppress the immune system and is being evaluated for its ability to help patients achieve complete remission of primary membranous nephropathy, which means the disease symptoms are reduced or disappear.

What is already known about the treatment

Zanubrutinib – Zanubrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating primary membranous nephropathy, a kidney condition. The medication works by inhibiting a specific enzyme called Bruton's tyrosine kinase, which plays a role in the immune system and inflammation. This action helps reduce proteinuria, a condition where excess protein is found in urine, which is a common symptom of primary membranous nephropathy. Zanubrutinib is classified as a Bruton's tyrosine kinase inhibitor.

Investigated diseases

Primary Membranous Nephropathy – This is a kidney disorder characterized by the thickening of the membranes within the glomeruli, which are tiny blood vessels in the kidneys. The condition leads to the leakage of proteins from the blood into the urine, a condition known as proteinuria. Over time, this protein leakage can cause swelling in various parts of the body, particularly in the legs and around the eyes. The disease progresses slowly and can lead to a gradual decline in kidney function. It is considered a rare disease and often requires careful monitoring to manage symptoms and prevent complications.