(22040 ALPINE 1) A Phase 2b dose-finding, randomized, placebo-controlled, double-blind study to evaluate efficacy and safety of BAY 3283142 on top of standard of care in reducing albuminuria in patients with chronic kidney disease
This research study, called ALPINE 1, is looking into a new medication named BAY 3283142. It's for adults who have long-term (chronic) kidney disease. The main goal is to find the best dose of this new medicine and see how well it works and if it's safe. We'll be comparing it to a dummy pill (placebo) to understand its effect better. Researchers will be especially interested in whether it can reduce a type of protein called albumin in your urine, as this is a sign of kidney damage. This study is an important step in developing new ways to help manage chronic kidney disease and improve kidney health.
At a glance
What is this study about?
Imagine your kidneys are like very important filters in your body, cleaning your blood. When you have chronic kidney disease, these filters aren't working as well as they should. Sometimes, a protein called albumin starts to leak into your urine. This is a sign that your kidneys are under stress and can indicate that the damage is getting worse.
This study, called ALPINE 1, is trying to find a new way to help your kidneys. We are testing a new medicine, BAY 3283142, to see if it can reduce the amount of albumin leaking into your urine. Reducing albumin could mean better protection for your kidneys over time. Participants will receive either the new medicine or a dummy pill (placebo), alongside their usual kidney treatments, so we can fairly compare the effects. This helps us understand if the new medicine is effective and safe.
Finding treatments that can slow down kidney damage is very important, as chronic kidney disease can sometimes lead to more serious health problems. This study is a crucial step in discovering new and better ways to help people living with this condition and improve their long-term health.
Key takeaways
- This study tests a new medicine for chronic kidney disease.
- It aims to reduce protein (albumin) in urine, a sign of kidney damage.
- Participants will receive either the new medicine or a dummy pill.
- The study lasts 16 weeks with regular health checks.
- It's a 'Phase II' study, focused on finding the best dose and checking safety.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adult volunteers, aged 18 and over, who have long-term kidney disease. Both men and women can take part. There will be specific medical checks to make sure the study is suitable and safe for you.
To be eligible, your kidney disease will need to meet certain criteria, which the study doctors will explain. You will also already be receiving standard care for your kidney condition. The research team will review your medical history and current health to determine if this study is a good fit for you.
It's important to discuss your full medical history and all your current medications with the study team, as some health conditions or medicines might mean you can't join the study.
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?
- Do you have a diagnosis of chronic kidney disease?
- Are you currently receiving standard care for your kidney condition?
- Are you willing to attend regular clinic visits and have blood/urine tests?
- Are you comfortable potentially receiving a placebo (dummy pill)?
What does participation involve?
If you decide to take part, you would receive either the new study medicine, BAY 3283142, or a dummy pill (placebo), along with your usual kidney medicine. Neither you nor the study team would know which you are receiving. You'd take this medicine for 16 weeks.
You would have several visits to the study clinic during this time. These visits would involve health checks, blood tests, and urine tests to measure things like your kidney function and the amount of albumin in your urine. The first few visits would be closer together, and later ones might be more spread out. The total duration of the study would involve taking the medication for 16 weeks, with follow-up appointments after that. The study team will explain the full schedule of visits and what each visit involves.
Potential risks and benefits
Locations (7)
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Common questions
What is chronic kidney disease?
Chronic kidney disease (CKD) means your kidneys are damaged and can't filter blood as well as they should, leading to waste build-up.
What is albumin in urine?
Albumin is a protein. Finding high levels in your urine can be a sign of kidney damage.
What does 'placebo' mean?
A placebo is a dummy pill that looks like the real medicine but contains no active drug, used to compare effects fairly.
Will I know if I'm getting the real medicine or the dummy pill?
No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting which treatment until after the study ends.
How long will I take the study medicine?
You would take the study medicine or placebo for 16 weeks, alongside your usual 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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