A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy
This research study is looking into a new medication called mezagitamab for adults who have a kidney condition known as Primary Immunoglobulin A Nephropathy, also called IgA nephropathy or Berger's disease. This condition affects the kidneys' filtering ability over time. Participants in this study are already receiving their regular, stable treatment for their kidney disease. This is an early-stage study (Phase 1), which means researchers are mainly focused on understanding how safe mezagitamab is and how it acts within the body. They want to see if it has any unexpected side effects and how it's handled by the body, rather than how effective it is at treating the disease at this stage. Both men and women aged 18 and older can take part.
At a glance
What is this study about?
This study is investigating a new medicine called mezagitamab, designed for adults living with Primary Immunoglobulin A Nephropathy, often shortened to IgA nephropathy or sometimes called Berger's disease. This condition is a chronic kidney disease where a specific antibody, immunoglobulin A, builds up in the kidneys, causing inflammation and damage over time. This can lead to the kidneys not working as well as they should, and in some cases, can lead to kidney failure.
The main goal of this particular study, which is an early-stage (Phase 1) clinical trial, is to understand more about mezagitamab itself. Researchers want to carefully look at how safe the medicine is when given to people, what side effects it might cause, and how the body processes it. This involves understanding how the medicine is absorbed, distributed, broken down, and removed from the body. It's not about seeing if the medicine cures the disease at this stage, but rather gathering important safety information before larger studies can begin.
Participants in this study will already be on their usual, stable treatments for IgA nephropathy. The new medicine, mezagitamab, will be given in addition to their existing care. This helps researchers see how the new medicine behaves without drastic changes to the patient's current health management. By learning more about mezagitamab's safety and how it works in the body, scientists can decide if it's promising enough to move forward into bigger studies that would then look at its effectiveness in treating IgA nephropathy.
Key takeaways
- This study evaluates a new medicine, mezagitamab, for IgA nephropathy.
- It's an early-stage study focusing on safety and how the medicine works in the body.
- Participants continue their usual kidney disease treatment.
- Open to adults aged 18 and older, both men and women.
- Participation involves regular clinic visits for medication and health checks.
- You can withdraw from the study at any time.
Who may be eligible?
Anyone thinking about joining this study needs to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part.
This study is open to both men and women. If you have been diagnosed with Primary Immunoglobulin A Nephropathy (IgA nephropathy or Berger's disease) and are currently receiving a stable, ongoing treatment for your condition, you might be eligible to participate. The research team will need to check your medical history and current health carefully to make sure the study is a safe and suitable option for you.
It's important to understand that there will be other specific health requirements not listed here that the study doctors will check. These checks are in place to ensure your safety and the quality of the study results. Talking to your doctor about your health history is the best way to understand if you might be a good fit.
- Are you 18 years old or older?
- Do you have a diagnosis of Primary IgA Nephropathy (Berger's disease)?
- Are you currently on a stable, ongoing treatment for your kidney condition?
- Are you able to attend regular clinic appointments as required by the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve several visits to the clinic for assessments. These will include physical examinations, blood and urine tests to monitor your kidney function and general health, and to see how your body is reacting to the new medicine. You would receive the study medication, mezagitamab, according to a schedule set by the research team. You would continue to take any stable background treatments for IgA nephropathy you are currently on.
There will also be follow-up appointments after you stop taking the study medicine to ensure your well-being and to collect final safety information. The total duration of your participation, including follow-up, would be fully explained to you before you agree to join. This includes specific details about how often you'd need to visit, the tests involved, and how long the study would run for you personally.
Potential risks and benefits
Locations (2)
- —Spain
- —Hungary
Common questions
What is IgA nephropathy (Berger's disease)?
It's a kidney disease where a type of protein, immunoglobulin A, builds up in the kidneys, causing inflammation and potentially harming their ability to filter waste over time.
What is 'Phase 1' of a clinical trial?
Phase 1 is an early stage of testing a new medicine in people. The main goal is to check how safe it is and how it works in the body, rather than how well it treats the disease.
Will I still take my regular kidney medicine if I join?
Yes, if you join this study, you will continue to take your usual, stable medication for IgA nephropathy alongside the new study medicine, mezagitamab.
Who can participate in this study?
Adults aged 18 and over, both men and women, who have IgA nephropathy and are on stable background treatment for their condition may be eligible.
What if I change my mind about participating?
You have the right to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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