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
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.
- Are you an adult between 18 and 75 years old?
- Have you been diagnosed with Primary Membranous Nephropathy (PMN) confirmed by a special blood test?
- Do you have high levels of protein in your urine?
- Are your kidneys currently functioning well enough (eGFR of 60 or more)?
- Are you currently taking ACE inhibitors or ARBs for your blood pressure, or willing to start them?
- Have you *not* had a rapid worsening of your kidney function recently?
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
Locations (40)
- Research SiteVerified postcodeLoma Linda, United States· Recruiting
- Research SiteVerified postcodeSan Diego, United States· Recruiting
- Research SiteVerified postcodeMinneapolis, United States· Recruiting
- Research SiteVerified postcodeRochester, United States· Recruiting
- Research SiteVerified postcodeHouston, United States· Recruiting
- Research SiteVerified postcodeBuenos Aires, Argentina· Recruiting
- Research SiteUnverifiedCABA, Argentina· Recruiting
- Research SiteUnverifiedCiudad de Buenos Aires, Argentina· Recruiting
- Research SiteVerified postcodeLa Plata, Argentina· Not yet recruiting
- Research SiteVerified postcodeRosario, Argentina· Recruiting
- Research SiteVerified postcodeSanta Fe, Argentina· Withdrawn
- Research SiteVerified postcodeSanta 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?
Discussion
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