RecruitingRare disease

Study on the Safety and Tolerability of Lixudebart and Rituximab for Patients with Rapidly Progressive Glomerulonephritis Due to ANCA-Associated Vasculitis

Fast replyRegistered drugNo placebo

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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 condition called Antineutrophil Cytoplasmic Antibody Associated Vasculitis (AAV), which can lead to a serious kidney problem known as rapidly progressive glomerulonephritis (RPGN). The study is testing a new treatment called ALE.F02, which is given through an intravenous infusion, meaning it is administered directly into the bloodstream. The purpose of the study is to evaluate the safety and tolerability of ALE.F02 in patients with RPGN due to AAV.

Participants in the study will receive either ALE.F02 or a placebo. The study will last for several weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if ALE.F02 can help protect the kidneys and improve kidney function in patients with this condition. Other medications that may be used in the study include Rituximab, a type of monoclonal antibody, and Cyclophosphamide, a chemical used in some treatments. These medications are also given through intravenous administration.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study will also look at how ALE.F02 affects kidney function over time, including changes in protein levels in the urine and overall kidney health. The goal is to find out if ALE.F02 can be a safe and effective treatment option for people with RPGN due to AAV, potentially offering a new way to manage this challenging condition.

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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, confirming your willingness to participate and comply with the study requirements.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history, conducting a physical examination, and performing necessary laboratory tests to ensure you meet the study criteria.
Step 3
Treatment administration
You will receive the study medication, ALE.F02, as a continuous intravenous infusion. The primary goal is to evaluate the safety and tolerability of this treatment in patients with rapidly progressive glomerulonephritis associated with antineutrophil cytoplasmic antibody vasculitis.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted to assess your health and the effects of the treatment. This includes blood tests, urine tests, and other necessary evaluations to track your progress and any side effects.
Step 5
End of treatment
The treatment period will conclude at Week 24 or at the end of treatment, whichever comes first. Your health and response to the treatment will be thoroughly evaluated.
Step 6
Final assessment
A final assessment will be conducted to evaluate the overall impact of the treatment on your condition. This includes a comprehensive review of your health status and any changes in your condition since the start of the study.

Who can join the trial?

11 criteria

Must be a male or female patient who is at least 18 years old.
Must have a score of less than 7 on the Clinical Frailty Scale, which measures how frail or weak a person is, based on their medical history and an interview.
Must weigh 130 kg or less.
Must be willing and able to follow the study requirements and provide informed consent, which means agreeing to participate after understanding the study details.
Must agree to have a kidney biopsy, which is a procedure to take a small sample of kidney tissue for testing, either before starting the study drug or have had one in the last 45 days.
Must have been newly diagnosed with **rapidly progressive glomerulonephritis (RPGN)** within the last 45 days, shown by reduced kidney function and a history of protein or blood in the urine.
Must be suspected of having RPGN due to **ANCA-associated vasculitis (AAV)**, based on specific lab tests, including a positive test for ANCA, which are antibodies that can attack the body’s own cells.
Female patients must not be pregnant or breastfeeding and must either use a highly effective birth control method or be unable to have children.
Female patients must agree not to donate eggs for 6 months after the last dose of the study drug.
Male patients must agree to use contraception, such as abstinence or a condom, during the study and for 90 days after the last dose of the study drug.
Male patients must agree not to donate sperm during the study and for 90 days after the last dose of the study drug.

Who cannot join the trial?

4 criteria

Patients who have a different type of kidney disease that is not **rapidly progressive glomerulonephritis**. This is a condition where the kidneys stop working properly very quickly.
Patients who are not within the specified age range for the study.
Patients who are not part of the specific group being studied.
Patients who are not able to give their consent or are considered part of a vulnerable population, which means they might need extra protection or care.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Region Midtjylland
Aarhus, Denmark
Responsive
Region Oestergoetland
Linkoping, Sweden

Trial locations

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Investigated drugs

ALE.F02 is a medication being tested in this clinical trial. It is given to patients through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein. The main goal of using this medication in the trial is to see if it is safe and well-tolerated by patients who have a specific type of kidney disease called rapidly progressive glomerulonephritis (RPGN), which is associated with a condition known as antineutrophil cytoplasmic antibody-associated vasculitis (AAV). Researchers are also interested in understanding how the body processes this medication and whether it can help protect the kidneys from damage in these patients.

What is already known about the treatment

ALE.F02 – ALE.F02 is administered through a continuous intravenous (IV) infusion, meaning it is delivered directly into the bloodstream over a period of time. Currently, this medication is being studied in clinical trials and is not yet widely available in medical practice. It is being investigated for its potential to treat rapidly progressive glomerulonephritis, a severe kidney condition associated with antineutrophil cytoplasmic antibody (ANCA) vasculitis. The medication works by targeting specific molecules involved in the immune response, aiming to reduce inflammation and prevent further kidney damage. ALE.F02 falls under the pharmacological classification of immunosuppressive agents, which are drugs that help to dampen the body's immune response.

Investigated diseases

Rapidly progressive glomerulonephritis – This disease is characterized by a swift decline in kidney function due to inflammation of the glomeruli, which are tiny filters in the kidneys. It progresses quickly, often over weeks to months, leading to a significant reduction in the kidneys' ability to filter waste from the blood. The inflammation causes damage to the glomeruli, resulting in symptoms such as blood in the urine, proteinuria, and reduced urine output. As the condition advances, it can lead to kidney failure if not managed. The disease is often associated with autoimmune conditions, where the body's immune system mistakenly attacks its own tissues.