Rescue of Nephrons With ALE.F02 (RENAL-F02)
This study, called RENAL-F02, is testing a new medication, ALE.F02, for people with ANCA-associated vasculitis (AAV), a condition where the body's immune system mistakenly attacks its own small blood vessels, often affecting the kidneys. The main aims are to find out if this new drug is safe, well-tolerated, and if it can help protect and preserve kidney function when added to standard treatments. Participants will receive either different doses of the new drug or a dummy treatment (placebo) alongside their usual care for 24 weeks. Researchers will monitor their health closely, including physical exams, blood and urine tests, and some scans.
At a glance
What is this study about?
This research study, known as RENAL-F02, is exploring a new treatment called ALE.F02. It's designed for individuals living with a condition called ANCA-associated vasculitis (AAV). AAV is an autoimmune disease, which means the body's own defence system, the immune system, mistakenly attacks healthy tissues. In AAV, it targets small blood vessels throughout the body. Because kidneys are full of these tiny blood vessels, they are very often affected, leading to problems with kidney function.
The main goals of this study are twofold. Firstly, the researchers want to ensure that the new drug, ALE.F02, is safe to use and that patients can tolerate it well. Secondly, they aim to discover if, when combined with standard medications, ALE.F02 can effectively protect the kidneys and help maintain their function in people with AAV. Your regular doctors will still manage your condition with the usual care, and this study aims to see if adding ALE.F02 can offer an extra layer of protection for your kidneys.
To do this, participants will be divided into groups. Some will receive different doses of ALE.F02 alongside their standard treatment, while others will receive their standard treatment plus a placebo (an inactive substance that looks just like the study drug). This comparison allows researchers to clearly see any effects of ALE.F02. The findings from this type of study are crucial for understanding new medicines and could potentially lead to better treatments for AAV affecting the kidneys.
Key takeaways
- This study is testing a new drug (ALE.F02) for ANCA-associated vasculitis affecting kidneys.
- It aims to check the safety and ability of ALE.F02 to protect kidney function.
- Participants will receive either different doses of the new drug or a dummy treatment (placebo).
- You'll have regular medical checks, blood, and urine tests over 24 weeks.
- You'll continue your standard kidney treatment alongside the study medication.
- Participation is voluntary, and you can withdraw at any time without affecting your care.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and generally well enough to participate, with a good level of independence in your daily life in the three months before your kidney problems started. You must also be willing to follow the study's requirements and give your informed consent to take part.
You would have been recently diagnosed (within 45 days of starting study treatment) with rapid progressive glomerulonephritis due to ANCA-associated vasculitis, affecting your kidney function. This includes having specific levels of kidney function (eGFR between 10 and 50) and signs of kidney damage like protein or blood in your urine. Your diagnosis would be supported by a positive ANCA test.
There are also some other criteria, such as weighing 130 kg or less. If you are a woman who could become pregnant, you must not be pregnant or breastfeeding and must agree to use effective contraception during and for a period after the study treatment. The research team will discuss all specific requirements with you to see if this study is a good fit.
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 18 years old or older?
- Have you recently been diagnosed with ANCA-associated vasculitis affecting your kidneys?
- Are you generally able to carry out your daily activities independently?
- If you're a woman, are you not pregnant or breastfeeding, and willing to use effective contraception?
- Are you willing to attend regular study visits and have blood/urine tests?
- Do you weigh 130 kg or less?
What does participation involve?
If you decide to take part in this study, the treatment period will last for 24 weeks. During this time, you'll receive 13 infusions of the study medication (either ALE.F02 or a placebo) in addition to your usual care for kidney inflammation caused by AAV. You'll have regular visits where the study team will conduct brief physical examinations, focusing on your skin and any existing medical conditions.
Throughout the study, blood and urine samples will be collected. These tests are important for routine safety checks and to monitor your kidney function. We'll also take extra blood samples to measure how the study medicine moves through your body, if your body produces antibodies against it, and to check for specific markers (biomarkers) that show how your body is responding to the treatment. Urine samples will also be collected to measure markers related to your vasculitis or inflammation. Women who could become pregnant will also have urine pregnancy tests.
Some participants may also have a special X-ray scan called a Chest HRCT scan. This is to check for vasculitis affecting the lungs. If your initial scan shows lung vasculitis, you'll have a follow-up scan at Week 24 to see if your lung condition has improved or worsened.
Potential risks and benefits
Locations (49)
- Vseobecna fakultni nemocnice v PrazeVerified postcodePrague, Czechia· Recruiting
- Institut klinicke a experimentalni medicinyVerified postcodePrague, Czechia· Recruiting
- Aalborg University HospitalVerified postcodeAalborg, Denmark· Recruiting
- Aarhus University HospitalVerified postcodeAarhus, Denmark· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Recruiting
- Odense University HospitalVerified postcodeOdense, Denmark· Recruiting
- Centre Hospitalier Boulogne sur MerVerified postcodeBoulogne-sur-Mer, France· Recruiting
- CHU Bordeaux - Hopital PellegrinVerified postcodeBordeaux, France· Recruiting
- CHRU de Brest - Hopital de la Cavale BlancheVerified postcodeBrest, France· Recruiting
- CHU Grenoble-Alpes - Hopital MichallonVerified postcodeLa Tronche, France· Recruiting
- CHU de Nantes - Hotel-DieuVerified postcodeNantes, France· Recruiting
- CHU de NimesVerified postcodeNîmes, France· Recruiting
Common questions
What is ANCA-associated vasculitis (AAV)?
AAV is a condition where your body's immune system attacks its own small blood vessels, often affecting organs like the kidneys.
What is a placebo?
A placebo is an inactive substance that looks exactly like the study drug but contains no active medication. It helps researchers compare the effects of the new drug.
How long will I be in the study?
The treatment period for this study lasts for 24 weeks, during which you'll have regular visits and receive infusions.
Will I still receive my usual kidney medication?
Yes, you will continue to receive your standard treatment for kidney inflammation due to AAV alongside the study medication or placebo.
Will I know if I'm getting the new drug or the placebo?
No, you won't know whether you're receiving the new drug or the placebo during the study. This helps ensure unbiased results.
How to find out more
Mohamed Benabed
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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