A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
This research study is looking at a new medicine called Ultomiris to see if it can help adults who have two specific kidney conditions: Lupus Nephritis (LN) or IgA Nephropathy (IgAN). These conditions can cause kidney damage. In this study, some participants will receive Ultomiris, while others will receive a placebo, which is a dummy medicine, to compare the effects. Doctors will be checking to see if Ultomiris helps reduce the amount of protein in people's urine, which is a sign of kidney improvement. They will also look at how well kidneys are working and if the medicine helps control other symptoms related to the conditions. This is a Phase 2 study, meaning it's an important step in understanding if the medicine is effective and safe.
At a glance
What is this study about?
This study is about exploring a new medicine called Ultomiris for two different kidney conditions: Lupus Nephritis and IgA Nephropathy. In both conditions, the kidneys become damaged, which can lead to serious health problems. The main goal of this study is to find out if Ultomiris can help reduce the amount of protein in your urine. Having too much protein in your urine (called proteinuria) is a key sign that your kidneys are not working as they should.
Researchers will compare Ultomiris to a 'placebo', which looks exactly like the real medicine but doesn't contain any active drug. This helps them understand if any changes seen are truly due to Ultomiris. For people with Lupus Nephritis, the study will also look at whether Ultomiris helps stop flare-ups of the disease and if patients can reduce their reliance on steroid medications. For those with IgA Nephropathy, the study will check if Ultomiris leads to a partial improvement in their kidney health.
This is a 'Phase 2' study, which means it's one of the earlier stages of drug development. The aim is to get a better understanding of how well the medicine works and if it's safe for people to use. The findings from this study will help doctors decide if Ultomiris should be tested in larger studies and potentially become a new treatment option in the future.
Key takeaways
- This study evaluates a new medicine, Ultomiris, for kidney conditions.
- It's for adults with Lupus Nephritis or IgA Nephropathy.
- The main aim is to see if it reduces protein in urine.
- Some participants will receive Ultomiris, others a dummy medicine.
- This is a Phase 2 study, checking effectiveness and safety.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Most importantly, you must have been diagnosed with either Lupus Nephritis or IgA Nephropathy. These are specific kidney conditions that the study is focusing on.
There will be other detailed health checks to make sure the study medicine is safe and appropriate for you. Your study doctor will discuss these with you.
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 Lupus Nephritis?
- OR do you have a diagnosis of IgA Nephropathy?
- Are you willing to attend regular clinic visits?
- Are you able to receive treatments through a drip into your arm?
What does participation involve?
If you decide to join this study, you'll be randomly assigned to receive either the study medicine, Ultomiris, or a dummy medicine called a placebo. You won't know which one you are receiving, and neither will your study doctor. The medicine will be given as a liquid through a drip into your arm (an infusion).
Throughout the study, you'll have regular visits to the clinic. At these visits, doctors and nurses will monitor your health closely. This will involve regular blood tests, urine tests to check protein levels and kidney function, and physical examinations. They will also ask you about any symptoms you're experiencing and how you're generally feeling. The total duration of your participation in the study, including follow-up, will be explained fully by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedNetherlands
Common questions
What is Lupus Nephritis?
Lupus Nephritis is a serious kidney inflammation caused by an autoimmune disease called Lupus, where the body's immune system attacks its own kidneys.
What is IgA Nephropathy?
IgA Nephropathy is a kidney disease where antibodies called IgA build up in the kidneys, causing inflammation and damage.
What does a 'placebo' mean?
A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.
Why is 'protein in urine' important?
Too much protein in your urine (proteinuria) is often a sign that your kidneys are damaged and not filtering waste properly. Reducing it can indicate improved kidney health.
What is a 'Phase 2' study?
A Phase 2 study is an early stage of research where doctors test a new medicine in a small group of people to see if it works and check for side effects, before larger studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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