Active not recruitingPHASE2, PHASE3INTERVENTIONAL

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

Researchers are conducting a study to look at a new medicine called zanubrutinib. This medicine is being tested in adults who have a kidney problem known as primary membranous nephropathy (PMN). The main goal of the study is to see how well zanubrutinib works in reducing the amount of protein in your urine, which is a key sign of PMN. In the first part of the study, they will check how effective zanubrutinib is on its own. In the second part, they will compare zanubrutinib with a commonly used medicine called tacrolimus, to see if it helps patients achieve full remission. This study aims to find better ways to treat PMN and improve the health of those with the condition.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

BeOne Medicines

Enrolment target

178

Start

17 Apr 2023

Estimated completion

01 Oct 2027

Primary Membranous Nephropathy

What is this study about?

This research is focused on a kidney condition called primary membranous nephropathy (PMN). In PMN, tiny filters in your kidneys become damaged, leading to too much protein leaking into your urine. This can cause swelling and, over time, may lead to kidney damage. Doctors are constantly looking for new and better treatments to help manage this condition and prevent it from getting worse.

This study is testing a new medicine called zanubrutinib. It's designed to see how effective and safe zanubrutinib is for adults living with PMN. The study is split into two main parts. First, they want to understand how well zanubrutinib alone reduces the protein in your urine. This is a vital sign that the treatment is working and helping your kidneys.

In the second part, the research will compare zanubrutinib with another medicine called tacrolimus, which is a common treatment for PMN. The goal here is to see if zanubrutinib can lead to a complete recovery more often than tacrolimus. Finding effective treatments like zanubrutinib could offer new hope for people with PMN, helping them manage their condition better and potentially avoiding severe kidney problems.

Key takeaways

This study evaluates zanubrutinib for primary membranous nephropathy (PMN).
It aims to reduce protein in urine and achieve full recovery.
Zanubrutinib is compared against the standard treatment, tacrolimus.
Participation involves regular clinic visits, tests, and taking study medication.
It could offer a new treatment option for PMN.

Who may be eligible?

To be able to join this study, you would need to have had a kidney biopsy that confirmed primary membranous nephropathy within the last five years. Also, your urine tests would need to show a certain level of protein leaking, and your doctor would need to confirm that you are taking a specific blood pressure medicine at the right dose, with good control over your blood pressure.

There are also some reasons why you might not be able to join. For example, if your kidney problems are due to another health issue, or if you have specific types of diabetes, severe kidney disease that's getting worse quickly, or certain infections like hepatitis or HIV. People with a history of severe heart or brain vessel problems, or a weakened immune system, would also not be able to participate. They're looking for adults between 18 and 75 years old, and both men and women can take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with primary membranous nephropathy by a kidney biopsy in the last 5 years?
Do your urine tests show high levels of protein currently?
Are you between 18 and 75 years old?
Do you have good control over your blood pressure while on specific medication?
Do you NOT have a secondary cause for your kidney disease (e.g., from another illness)?
Do you NOT have severe diabetes or certain serious infections?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for medical check-ups and assessments. You would receive either the study drug, zanubrutinib, or the comparison drug, tacrolimus. You'd need to have blood and urine tests done often to measure your protein levels, check your kidney and liver health, and monitor your blood pressure. The doctors would also ask you about any side effects you might experience. The total duration of your participation, including follow-up visits after stopping the study medicine, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer you access to a new treatment for your kidney condition before it's widely available. It could potentially help reduce the protein in your urine and improve your kidney health. However, like all medicines, zanubrutinib and tacrolimus can have side effects, which the study team will explain fully. There's also no guarantee that the treatment will work for everyone, and it's possible you could receive a placebo in some studies (though not this one specifically). You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (48)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Amicis Research Center
Verified postcode
Granada Hills, United States
Stanford University
Verified postcode
Palo Alto, United States
Intermed Consultants
Verified postcode
Minneapolis, United States
Kidney Specialist of Southern Nevada (Ksosn)
Verified postcode
Las Vegas, United States
University of Cincinnati College of Medicine
Verified postcode
Cincinnati, United States
Carolina Nephrology
Verified postcode
Spartanburg, United States
Instituto Pro Renal Brasil
Verified postcode
Curitiba, Brazil
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
Verified postcode
São Paulo, Brazil
Ott Healthcare, Inc (Corporate Medical Centre)
Verified postcode
Scarborough Village, Canada
Beijing An Zhen Hospital, Capital Medical University
Verified postcode
Beijing, China
Peking University First Hospital
Verified postcode
Beijing, China
Fujian Medical University Union Hospital
Verified postcode
Fuzhou, China

Common questions

What is primary membranous nephropathy?

It's a kidney condition where the filters in your kidneys become damaged, causing protein to leak into your urine, which can lead to swelling and kidney problems over time.

What is zanubrutinib?

It's a new medicine being tested in this study to see if it can help treat primary membranous nephropathy by reducing protein leakage from the kidneys.

What is tacrolimus?

Tacrolimus is a medicine commonly used to treat primary membranous nephropathy, and it's being compared with zanubrutinib in this study.

Will I know which treatment I am getting?

In some parts of the study, you might not know whether you are getting zanubrutinib or tacrolimus, as this helps researchers get unbiased results.

How long will I be in the study?

The study team will provide detailed information about the expected duration of the study, including all treatments and follow-up appointments.