RecruitingRare disease

A Study of ALXN1920 Compared to Placebo in Adults with Primary Membranous Nephropathy at High Risk for Disease Progression

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What is this trial about?

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

This study is looking at Primary Membranous Nephropathy, which is a kidney disease that causes damage to the filtering units of the kidneys, leading to protein leaking into the urine. The study will test a medicine called ALXN1920, which is also known by the code name TPP-3621. Some people in the study will receive ALXN1920 while others will receive placebo. The medicine will be given as an injection under the skin. The purpose of the study is to see how well ALXN1920 works compared to placebo in reducing the amount of protein in the urine of people with this kidney disease who are at high risk for the disease getting worse.

People taking part in this study will be adults between 18 and 75 years old who have been diagnosed with Primary Membranous Nephropathy through a positive blood test for a specific antibody called anti-PLA2R antibody. They will need to have high levels of protein in their urine despite being treated with standard blood pressure medicines for at least eight weeks. During the study, participants will continue taking their usual kidney disease treatments along with the study medicine or placebo. The study will last up to 26 weeks, and doctors will regularly check the amount of protein in the urine, blood test results, and overall health of the participants.

Throughout the study, doctors will measure changes in protein levels in the urine, blood albumin levels, which is a protein that can be low in people with this kidney disease, and levels of the anti-PLA2R antibody in the blood. They will also count certain immune cells called CD20+ B cells in the blood and check various markers in the urine and blood. The study team will monitor for any side effects and measure how much of the study medicine is in the body over time. Additionally, they will check if the body develops any immune response to the study medicine.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Upon joining the study, your blood pressure medication (ACE inhibitors or ARB) will be continued. These medications help control blood pressure and reduce protein loss in urine.
Your doctor will ensure that the dose of this medication has been adjusted to the highest level you can tolerate.
You will receive prophylactic antibiotics to reduce the risk of infections during the study. These are preventive antibiotics taken to protect you while receiving other study treatments.
You will be vaccinated against Neisseria meningitidis, a type of bacteria that can cause serious infections.
Step 2
Study medication administration
You will be assigned to receive either ALXN1920 or placebo. A placebo is an inactive substance that looks like the study medication but contains no active treatment.
The study medication will be administered as an injection under the skin (subcutaneous injection).
The assignment to ALXN1920 or placebo will be done randomly, similar to flipping a coin, and neither you nor your doctor will know which treatment you are receiving during the study.
Step 3
Regular monitoring visits
Throughout the study, you will attend scheduled visits at the study site.
During these visits, urine samples will be collected to measure the amount of protein in your urine. This may include both 24-hour urine collections and single urine samples.
Blood samples will be taken to measure various substances, including albumin levels (a protein in blood), anti-PLA2R antibody levels (antibodies related to your kidney condition), and CD20+ B cell counts (a type of immune cell).
Your blood pressure will be measured regularly.
Electrocardiograms (ECGs) will be performed. This is a test that records the electrical activity of your heart.
Your doctor will check for any side effects or health changes you may experience.
Step 4
Safety assessments
Throughout the study, you will be monitored for any adverse events, which are any unwanted medical occurrences or side effects.
Additional blood and urine tests will be performed to check for specific markers related to kidney function and the study medication's effects on your body.
Tests will be conducted to measure the concentration of ALXN1920 in your blood and urine to understand how your body processes the medication.
Your immune response to the study medication will be assessed by checking for anti-drug antibodies, which are antibodies your body might produce in response to the medication.
Step 5
Completion of treatment period
The study treatment period will continue according to the protocol schedule.
You will continue to attend all scheduled visits and complete all required assessments.
The study is expected to continue until March 2027, though your individual participation duration will be specified by your study doctor.

Who can join the trial?

15 criteria

You must be between 18 and 75 years old at the time you sign the consent form to join the study
You must have a confirmed diagnosis of Primary Membranous Nephropathy, which is a kidney disease where the filtering parts of your kidneys become damaged
Your diagnosis must be confirmed by a blood test showing anti-PLA2R antibody levels greater than 50 RU/mL. These are specific proteins in your blood that indicate this kidney condition
You must be at high risk for your kidney disease getting worse, which means you need to meet certain requirements about your blood pressure medication and protein levels in your urine
You must have been taking ACE inhibitors or ARB medications for at least 8 weeks before joining. These are blood pressure medications that also help protect your kidneys. The dose should be at the highest level you can tolerate
If you have not been on these blood pressure medications for 8 weeks yet, you may enter a preparation period of up to 8 weeks
Your blood pressure must be below 140 mmHg in at least 75% of readings taken over the past 8 weeks while on these medications
You must have two separate measurements showing high levels of protein in your urine, each showing more than 3.5 grams per day. The second measurement should not show more than a 50% decrease from the first
You can be male or female
You must agree to follow the birth control methods required by the study
You must sign the informed consent form, which means you understand and agree to follow the study rules and requirements
You must be willing to provide consent for optional genetic research samples if you choose to participate in that part
You must be willing to receive the standard background care treatments
You must be willing to take antibiotic medications to prevent infections while receiving the study treatment
You must be willing to receive a vaccine against Neisseria meningitidis, which is a type of bacteria that can cause serious infections

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed information about who cannot join this clinical trial, it is not possible to list the specific conditions or situations that would prevent participation
Generally, exclusion criteria in clinical trials may include things like other serious health problems, certain medications being taken, pregnancy, or laboratory test results that fall outside acceptable ranges, but the specific criteria for this study are not available in the provided information

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Verified sites

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Centre Hospitalier Universitaire De Nice
Nice, France
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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
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Fundacio Puigvert
Barcelona, Spain

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Investigated drugs

ALXN1920
is an experimental medication being tested in this clinical trial for people with primary membranous nephropathy, a kidney disease. This medicine is being studied to see if it can help reduce the amount of protein in the urine, which is a sign of kidney damage. The medication is given to participants who have a high risk of their kidney disease getting worse.
Placebo
is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against ALXN1920 to help researchers understand if the real medication is working better than no treatment.

ALXN1920

What is already known about the treatment

ALXN1920 – ALXN1920 is an investigational medication currently being studied in clinical trials for the treatment of Primary Membranous Nephropathy (PMN), a kidney disease that causes protein to leak into the urine and can lead to kidney damage. The drug is administered to adult patients who have a high risk of their disease getting worse, with the goal of reducing protein levels in the urine. While the specific mechanism of action at the molecular level is not detailed in the available trial information, the medication is being tested to determine if it is effective, safe, and well-tolerated compared to placebo treatment. This drug is still in the Phase 2a stage of clinical development, meaning it is in early testing to evaluate its potential benefits and safety profile in humans.

Investigated diseases

Primary Membranous Nephropathy – Primary Membranous Nephropathy is a kidney disease that affects the filters in the kidneys called glomeruli. The disease occurs when the immune system mistakenly attacks the kidney's filtering membranes, causing them to become thick and damaged. This damage leads to protein leaking from the blood into the urine, a condition called proteinuria. As the disease progresses, the kidneys gradually lose their ability to filter waste properly. People with this condition may experience swelling in their legs and ankles due to fluid retention and low levels of protein in the blood. The disease can progress at different rates, with some individuals experiencing a more rapid decline in kidney function than others.