Phase 2, multicenter, randomized, open-label, controlled, 2-arm cross-over study to evaluate the clinical efficacy and safety of a renin inhibitor, aliskiren, compared to an angiotensin converting enzyme inhibitor, enalapril, in children and adults with C3 glomerulopathy
This research study is for people aged 18 and over who have a rare kidney condition called C3 glomerulopathy. We are comparing two existing medicines, aliskiren (Rasilez) and enalapril (Enalapril Viatris), to see which one might be better at treating the disease. The study aims to understand if these medicines can help reduce kidney damage and improve how your kidneys work. Participants will try both medicines during the study, taking one for a while and then switching to the other. We will monitor your health closely, including blood tests to check your C3 levels (a key marker for this condition) and your kidney function. The goal is to find safer and more effective ways to manage C3 glomerulopathy.
At a glance
What is this study about?
This research study is about finding better treatments for a rare and serious kidney disease called C3 glomerulopathy. In this condition, a part of your immune system, called the complement system, doesn't work correctly. This can cause damage to the filters in your kidneys, which are responsible for cleaning your blood. Over time, this damage can lead to serious kidney problems.
Researchers are looking at two different medicines that are already used for other conditions, aliskiren and enalapril. They both work by affecting how your body controls blood pressure and protects your kidneys. Doctors want to see if these medicines can help reduce the harmful effects of C3 glomerulopathy and protect your kidney health. This is a "Phase 2" study, which means it's an early stage where doctors are testing if the medicines are effective and safe in a group of people with the condition.
The main things doctors will be looking at are the levels of C3 in your blood (because it's a key marker of this disease) and how well your kidneys are working. They will also check other things like your blood pressure and how your immune system is behaving. By carefully comparing these two medicines, we hope to learn more about how they can help people with C3 glomerulopathy.
Key takeaways
- The study is for adults with a rare kidney disease called C3 glomerulopathy.
- It compares two existing medicines: aliskiren and enalapril.
- Participants will switch between both medicines during the study.
- Doctors will monitor your kidney health, C3 levels, and blood pressure.
- The aim is to find better ways to treat C3 glomerulopathy.
- You can stop participating at any time.
Who may be eligible?
This study is specifically looking for adults, so you need to be at least 18 years old to take part. There's no upper age limit. Both men and women can join this research.
When we say "C3 glomerulopathy," it means you must have been diagnosed with this particular kidney condition. The doctors in the study will need to confirm your diagnosis to make sure the study is right for you. They will also check your overall health to ensure it's safe for you to take the study medicines.
The research team will review your medical history and conduct some tests to see if you meet all the requirements for taking part. It's important that you discuss your full medical history with the study doctors.
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 been diagnosed with C3 glomerulopathy?
- Are you able to attend regular hospital visits?
- Are you willing to take study medication as directed?
- Are you comfortable with blood tests and possibly a kidney biopsy?
- Do you understand that you will try both study medicines?
What does participation involve?
If you decide to take part, you'll be assigned to take either aliskiren or enalapril first. After a period, you'll switch to the other medicine. This is called a 'cross-over' study, meaning everyone will try both treatments at different times. You will be given the study medicines, which are in tablet form.
Throughout the study, you'll have regular hospital visits for check-ups. These visits will involve blood tests to measure your C3 levels and kidney function, urine tests to check for protein, and blood pressure measurements. Some participants might also have kidney biopsies, which involve taking a small sample of kidney tissue for examination. This helps doctors see how the disease is affecting your kidneys and if the medicine is helping.
There might also be an 'extension study' after the main part, where you continue taking the medicine that proved most helpful. The total length of your participation will depend on the study design and whether you join the extension, but all of this will be clearly explained before you agree to take part.
Potential risks and benefits
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Common questions
What is C3 glomerulopathy?
It's a rare kidney disease where a part of your immune system damages your kidney filters, which clean your blood.
What medicines are being studied?
We are comparing two medicines, aliskiren (Rasilez) and enalapril (Enalapril Viatris), which are already used for other conditions.
Will I take both medicines?
Yes, in this study, you will take one medicine for a period, then switch to the other. Everyone tries both.
What blood tests will be done?
Doctors will check your C3 levels and how well your kidneys are working, among other things.
Can I leave the study if I want to?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your regular care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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