A Phase 2 Proof of Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OMS906 in Patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)
This research is looking at a new medicine called OMS906, designed for people with two specific kidney conditions: C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). It's an early-stage study, meaning we're still learning a lot about this potential treatment. The main goals are to find out if OMS906 is safe to use and how well people tolerate it, meaning if they have uncomfortable side effects. We also want to understand how the medicine moves through the body and starts to work. Importantly, we're trying to get an early idea of whether it can help improve kidney health in those affected by these conditions. Your safety and well-being are the top priorities throughout the study.
At a glance
What is this study about?
This study is a research project focusing on a new medicine, OMS906, for two types of kidney disease: C3 Glomerulopathy (known as C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). Both of these conditions involve damage to the tiny filters in your kidneys, which can lead to serious health problems over time. Because these are specific and often challenging conditions, researchers are continuously looking for new and better ways to treat them.
The main aim of this study is to explore several key things about OMS906. Firstly, we want to make sure it's safe for people to take and that any side effects are manageable. We'll be closely monitoring every participant for any unwelcome effects. Secondly, we're interested in understanding how the medicine behaves in the body – how much is absorbed, how long it stays, and if it reaches the right places to do its job. This helps us work out the best way to give the medicine in the future.
Finally, and very importantly, this study is looking for early signs that OMS906 might actually help improve the kidney conditions. We'll be checking various things related to kidney function, such as levels of protein in the urine, which can be a sign of kidney damage. While this is an early-stage study, the findings will be crucial for deciding whether OMS906 has the potential to become a useful new treatment option for people living with C3G or ICGN. Your involvement could help advance our understanding and treatment of these diseases.
Key takeaways
- This study is testing a new medicine called OMS906 for specific kidney diseases (C3G and ICGN).
- It's an early-stage study focusing on safety, how the medicine works, and early signs of it being effective.
- Participation involves regular clinic visits for health checks, blood, and urine tests.
- The study lasts for about 48 weeks with follow-up appointments.
- You must be 18 years or older and have a diagnosis of C3G or ICGN to be eligible.
- Your safety is the top priority, and you can leave the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
In addition to your age and gender, you must have a formal diagnosis of either C3 Glomerulopathy (C3G) or Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). These are the specific kidney conditions that the new medicine, OMS906, is designed to treat.
There will also be other health checks and medical criteria that your doctor will discuss with you. These are in place to ensure your safety throughout the study and that the research results are as clear and useful as possible. It’s important to talk openly with your doctor about all your medical history and any other medications you are taking.
- Are you 18 years old or older?
- Have you been diagnosed with C3 Glomerulopathy (C3G)?
- Or have you been diagnosed with Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)?
- Are you willing to attend regular clinic appointments for about a year?
- Are you comfortable with having blood and urine samples taken regularly?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the new medicine, OMS906, according to a specific plan set by the research team. You will have regular visits to the clinic, where doctors and nurses will check your health. These checks will include things like measuring your blood pressure and heart rate (vital signs), performing heart tests (ECGs), and taking blood and urine samples for various laboratory tests.
These tests will help the doctors understand how your body is responding to the medicine, whether it's safe for you, and if it's having any positive effects on your kidney condition. You'll be monitored closely for 48 weeks (just under a year), with check-ups at certain points like 12, 24, and 48 weeks. Even after stopping the medicine, there might be some follow-up appointments to ensure your continued well-being. The total length of your involvement will be thoroughly explained.
Potential risks and benefits
Locations (2)
- —Lithuania
- —Poland
Common questions
What are C3G and ICGN?
These are specific kidney diseases where the tiny filters in your kidneys get damaged, affecting how well your kidneys work.
What is OMS906?
OMS906 is a new medicine being tested in this study to see if it can help people with C3G and ICGN.
What does 'Phase 2' mean?
It means this is an early stage study. We're looking at the safety and how the medicine works, not just if it's safe but also if it shows early signs of helping.
Will I definitely get better if I join?
Not necessarily. This is a research study to find out if the medicine works. It's possible it may not help your condition, or you might experience side effects.
How long will I be in the study?
The main part of the study involves monitoring you for 48 weeks (just under a year) while you take the medicine, with some follow-up checks afterwards.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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