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RecruitingPHASE2INTERVENTIONAL

Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)

This research study is investigating a new medication, ALXN1920, for adult patients living with Primary Membranous Nephropathy (PMN). PMN is a serious kidney condition. We want to see if ALXN1920 can reduce how much protein leaves the body in urine, which is a sign of how well the kidneys are working. Participants in the study will be at a higher risk of their kidney disease progressing. Half of the participants will receive ALXN1920, and the other half will receive a dummy medication called a placebo. This helps us understand if the new medicine is effective. The main aim is to compare how well ALXN1920 works against the placebo in improving kidney health for people with PMN.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Alexion Pharmaceuticals, Inc.
Enrolment target
30
Start
19 Sep 2025
Estimated completion
09 Jul 2027

What is this study about?

This research study is focused on a kidney condition called Primary Membranous Nephropathy (PMN). In PMN, tiny filters in your kidneys, called glomeruli, become damaged, leading to too much protein leaking from your blood into your urine. Over time, this can cause serious kidney problems and potentially lead to kidney failure.

The purpose of this study is to test a new medicine, ALXN1920, to see if it can help people with PMN. We want to find out if this medicine can lower the amount of protein in your urine, which would be a sign that your kidneys are working better. We are particularly looking for people whose PMN is considered high-risk, meaning there's a greater chance their kidney function could get worse.

To make sure we accurately measure the effect of ALXN1920, some participants will receive the new medicine, while others will receive a placebo – a treatment that looks the same but contains no active medicine. This is a common way to test new drugs and helps us understand if ALXN1920 truly makes a difference compared to having no active treatment. All participants will also continue to receive their usual care for PMN throughout the study.

Key takeaways

  • Tests a new medicine (ALXN1920) for Primary Membranous Nephropathy (PMN).
  • Aims to reduce protein leakage in urine for high-risk PMN patients.
  • Compares ALXN1920 to a dummy treatment (placebo).
  • Requires adults aged 18-75 with confirmed PMN.
  • Close monitoring of kidney health throughout the study.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be an adult between 18 and 75 years old and have been diagnosed with Primary Membranous Nephropathy (PMN). Your diagnosis needs to be confirmed by a specific blood test showing a certain level of a marker called anti-PLA2R antibody. You must also be considered at high risk for your kidney disease getting worse. This includes having high levels of protein in your urine on two separate occasions and having healthy kidney function (at least 60 mL/min/1.73 m2).

You also need to be taking certain blood pressure medicines (ACE inhibitors or ARBs) for at least 8 weeks at a stable dose, or be willing to start this treatment. If you are taking another medicine called Rituximab for your PMN, you must be willing to take antibiotics to prevent infections and have certain vaccinations.

There are also reasons why you might not be able to join. For example, if your kidney function is getting worse very quickly, or if you've had a kidney transplant, a planned transplant, or need dialysis. If you have any other serious health conditions that could interfere with the study, or if you've had a serious, life-threatening kidney issue called Nephrotic Syndrome within the last year, you would not be able to participate.

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.

  1. Are you an adult between 18 and 75 years old?
  2. Have you been diagnosed with Primary Membranous Nephropathy (PMN) confirmed by a special blood test?
  3. Do you have high levels of protein in your urine?
  4. Are your kidneys currently functioning well enough (eGFR of 60 or more)?
  5. Are you currently taking ACE inhibitors or ARBs for your blood pressure, or willing to start them?
  6. Have you *not* had a rapid worsening of your kidney function recently?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups, blood tests, and urine tests to monitor your kidney function and general health. You would receive either the study medicine, ALXN1920, or a placebo, which looks like the real medicine but contains no active drug. You would also continue to receive your usual standard care for PMN. The study team will explain exactly what tests you'll have, how often your visits will be, and how long you'll be involved in the study. You will also need to take antibiotics if you are on Rituximab and ensure you are up to date on specific vaccinations.

Potential risks and benefits

Potential benefits of joining this study could include receiving a new, potentially effective medicine for your PMN that is not yet widely available. Your health will also be closely monitored by a team of medical professionals. However, there are potential risks, as with any new medicine. You might experience side effects from the study drug, or the placebo might not improve your condition. All possible side effects will be fully explained to you before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (40)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Loma Linda, United States· Recruiting
  • Research Site
    Verified postcode
    San Diego, United States· Recruiting
  • Research Site
    Verified postcode
    Minneapolis, United States· Recruiting
  • Research Site
    Verified postcode
    Rochester, United States· Recruiting
  • Research Site
    Verified postcode
    Houston, United States· Recruiting
  • Research Site
    Verified postcode
    Buenos Aires, Argentina· Recruiting
  • Research Site
    Unverified
    CABA, Argentina· Recruiting
  • Research Site
    Unverified
    Ciudad de Buenos Aires, Argentina· Recruiting
  • Research Site
    Verified postcode
    La Plata, Argentina· Not yet recruiting
  • Research Site
    Verified postcode
    Rosario, Argentina· Recruiting
  • Research Site
    Verified postcode
    Santa Fe, Argentina· Withdrawn
  • Research Site
    Verified postcode
    Santa Fe, Argentina· Withdrawn

Common questions

What is Primary Membranous Nephropathy (PMN)?

It's a kidney disease where the filters in your kidneys become damaged, causing protein to leak into your urine. Over time, it can lead to serious kidney problems.

What is ALXN1920?

ALXN1920 is a new medicine being tested in this study to see if it can help people with PMN by reducing protein in their urine.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the study medicine but contains no active drug. It helps researchers compare the new medicine's effects.

Why do some people get a placebo?

Giving some people a placebo helps researchers determine if the new medicine truly works better than no active treatment. It's a standard way to test new drugs.

How long will the study last?

The study team will explain the exact duration during the consent process, as it can vary for each participant.

How to find out more

Alexion Pharmaceuticals, Inc. (Sponsor)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of ALXN1920 in Adult Participants With Primary Membran…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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