SABINE - The efficacy and Safety of delayed-release Budesonide in children with primary IgA nephropathy - a multicenter, interventional phase III, randomized, placebo-controlled, double-blind study.
The SABINE study is investigating a new treatment for children with a specific kidney condition called primary IgA nephropathy. This condition causes the kidneys to not work as well as they should. The study will test a medicine called budesonide, which is given in a special way to release slowly. Researchers want to see if this medicine can reduce the amount of protein in a child’s urine (a sign of kidney problems) and if it is safe to use. Half the children will receive the study medicine, and the other half will receive a dummy medicine (placebo) – neither the child, their family, nor their doctors will know which one they are getting until the end of the study. This helps to ensure the results are accurate.
At a glance
What is this study about?
The SABINE study is all about finding a better way to help children who have a kidney problem called primary IgA nephropathy. This is a condition where the body's immune system mistakenly attacks the kidneys, which can stop them from cleaning the blood properly. Because of this, important proteins can leak into the urine, which isn't good for kidney health.
Researchers are testing a medicine called budesonide. This isn't just any budesonide; it's a special type that's designed to release the medicine slowly in the body. The main goal is to see if this special budesonide can help reduce the amount of protein found in children's urine after 24 weeks of treatment. They will also be closely watching to make sure the medicine is safe and doesn't cause too many side effects.
To make sure the study results are fair and accurate, some children will receive the active medicine, while others will receive a 'dummy' medicine called a placebo, which looks exactly the same but contains no active drug. This is a common and important way to test new medicines. Neither the participants, their families, nor their doctors will know who is receiving which treatment until the study is over. This helps researchers understand the true benefits and risks of the new medicine.
Key takeaways
- The SABINE study is for children with a specific kidney condition called IgA nephropathy.
- It tests a new, slowly-released medicine called budesonide.
- The main aim is to see if the medicine reduces protein in urine and is safe.
- Some children will get the active medicine, others a dummy medicine (placebo).
- Neither participants nor doctors will know who gets which treatment (double-blind).
- Participation includes taking medicine for 24 weeks and regular check-ups.
Who may be eligible?
This study is particularly looking for children who have been diagnosed with something called 'primary IgA nephropathy.' This means they have a specific kidney condition.
There isn't a specific age limit mentioned, so it might be open to children of all ages who fit the main diagnosis. Also, both boys and girls are welcome to take part in this study.
Further specific criteria for joining, such as other health conditions or medicines a child might be taking, would be discussed by the study team to ensure it's safe and appropriate for your child to participate.
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.
- Has your child been diagnosed with primary IgA nephropathy?
- Is your child able to take tablets or capsules?
- Are you able to attend regular clinic visits for your child?
- Do you understand that your child might receive a dummy medicine?
What does participation involve?
If your child takes part in this study, they will receive either the study medicine (delayed-release budesonide) or a dummy medicine (placebo) in tablet or capsule form. You won't know which one they are getting. Your child will need to take this medicine for 24 weeks. Throughout the study, there will be regular visits to the clinic so doctors can check on your child's health, take urine and blood samples to measure protein levels and kidney function, and keep an eye out for any side effects. After the 24 weeks of treatment, there will also be follow-up appointments to see how your child is doing. The full duration of your child's participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is IgA nephropathy?
It's a kidney condition where special proteins called IgA can build up in the kidneys, making them work less well and causing protein to leak into the urine.
What is 'delayed-release budesonide'?
It's a special form of medicine designed to break down and release the drug slowly in your child's body, usually targeting a specific area like the gut to help with conditions that affect the kidneys.
What does 'placebo-controlled' mean?
It means some children will receive the actual medicine, and others will receive a 'dummy' pill that looks the same but contains no active medicine. This helps researchers compare the effects accurately.
Will my child know if they are getting the real medicine?
No, neither your child, you, nor the doctors will know who is getting the real medicine or the placebo until the study is finished. This is called 'double-blind' and helps ensure fair results.
How long will my child need to take the study medicine?
Your child will take the study medicine for 24 weeks (about 6 months). There will also be follow-up check-ups after this period.
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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