A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients
This clinical trial is investigating a new treatment, LNP023, for people with IgA nephropathy, a kidney disease. Researchers want to find out if this new medication is both safe and effective. Participants will be randomly assigned to receive either LNP023 or a placebo (a dummy pill with no active medicine). The study will compare how these groups fare, looking at things like how much protein is in their urine and how well their kidneys are working over 9 to 24 months. This is a large, important study (Phase III) designed to confirm if LNP023 could become a new option for patients, aiming to slow down kidney damage and improve their quality of life.
At a glance
What is this study about?
This study is a research project looking for better ways to treat a kidney condition called IgA nephropathy. In this condition, the immune system mistakenly attacks the kidneys, which can lead to damage over time. Researchers are testing a new medication called LNP023 to see if it can help protect the kidneys and reduce the impact of the disease.
To get clear results, the study is set up so that some people will receive the new medicine, LNP023, and others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers understand whether any improvements are truly due to the new medicine or other factors. Neither you nor your doctor will know whether you are taking LNP023 or the placebo, which is why it's called "double-blind."
The main goals are to see if LNP023 can reduce the amount of protein leaking into your urine, which is a common sign of kidney damage in IgA nephropathy. They will also track how well your kidneys are working over 9 to 24 months. They want to know if the medicine helps slow down any decline in kidney function and prevents serious kidney problems in the long term. Safety is also a major focus, making sure any potential benefits outweigh the risks.
Key takeaways
- This study is testing a new drug, LNP023, for IgA nephropathy.
- It aims to see if LNP023 can reduce kidney damage and improve kidney function.
- Participants will receive either LNP023 or a dummy pill (placebo).
- The study will last up to 24 months, with regular health check-ups.
- Both men and women aged 18 and over are eligible.
- Your health will be closely monitored for safety and effectiveness.
Who may be eligible?
This study is open to both men and women aged 18 or older.
To be considered for this study, you must have been diagnosed with primary IgA nephropathy. There will be other specific health requirements that the study doctors will check to make sure the study is a good fit for you.
It's important to discuss your full medical history with the study team to see if you meet all the criteria.
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 primary IgA nephropathy?
- Are you comfortable with regular clinic visits and tests?
- Are you able to take a daily medication as prescribed?
- Are you willing to potentially receive a placebo instead of the active drug?
What does participation involve?
If you decide to take part, you would be randomly assigned to one of two groups: one receiving the active study medicine (LNP023) or one receiving a placebo (a dummy pill). You would take the assigned medication every day.
Over the course of the study, you would have regular visits to the clinic for medical check-ups. These visits would include blood tests, urine tests (including collecting your urine for 24 hours to measure protein levels), and checks of your overall health and vital signs. You would also be asked to complete questionnaires about how you are feeling, particularly regarding fatigue.
The study will closely monitor your kidney function and general health for up to 24 months. Regular follow-up appointments are necessary to make sure the treatment is safe and to track any changes in your condition.
Potential risks and benefits
Locations (12)
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedSlovenia
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedSweden
- —UnverifiedSlovakia
- —UnverifiedGermany
Common questions
What is IgA nephropathy?
It's a kidney disease where a type of protein, IgA, builds up in the kidneys, causing damage and affecting their ability to filter blood.
What is a placebo?
A placebo is a pill that looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.
What does 'double-blind' mean?
It means neither you nor your doctor will know if you are receiving the active study medication or the placebo. This prevents bias in the results.
How long will the study last?
The study will track participants for up to 24 months, with regular check-ups during that time.
What is eGFR?
eGFR stands for 'estimated Glomerular Filtration Rate' and is a measure that tells doctors how well your kidneys are filtering waste from your blood.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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