A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY
IgA nephropathy is an illness where your immune system mistakenly damages the tiny filters inside your kidneys. This damage causes protein and blood to leak into your urine. When kidney symptoms suddenly worsen (a flare-up), doctors usually prescribe steroid tablets. However, steroids do not work well for everyone. This clinical trial is testing a medicine called ravulizumab (brand name Ultomiris). The medicine is given directly into a vein through a drip. Researchers want to find out whether ravulizumab can safely calm kidney inflammation and reduce the amount of protein and blood in the urine for people who have not responded to standard steroid treatment. Participants receive the treatment for 26 weeks (about six months) and are then followed up until week 46. The study checks how well the medicine protects kidney health and watches carefully for any unwanted side effects.
At a glance
What is this study about?
IgA nephropathy is an autoimmune condition affecting the kidneys. In a healthy body, antibodies help fight off bugs and infections. In people with IgA nephropathy, an antibody called IgA builds up inside the kidneys instead. This causes inflammation and swelling in the tiny filters that clean your blood, making it harder for the kidneys to do their job properly.
From time to time, the condition can suddenly flare up. A flare can cause visible or hidden blood in the urine, protein loss, and a drop in overall kidney function. Doctors usually try to calm flares down using strong steroid medications. However, some people have 'steroid-resistant' disease, meaning standard steroid tablets do not stop the inflammation. Without effective treatment, repeated flares can cause lasting kidney damage.
This study looks at a targeted treatment called ravulizumab (Ultomiris). Ravulizumab works by switching off a specific part of the immune system that drives inflammation in the kidneys. By giving the medicine through a drip, doctors hope to quieten the immune attack, give the kidneys a chance to heal, and stop valuable protein from leaking into the urine.
If the study is successful, it could provide doctors with a valuable new treatment option for people whose kidney disease does not respond to regular medications. This could help preserve kidney function and protect patients from long-term kidney failure.
Key takeaways
- Tests ravulizumab (Ultomiris) for people with IgA nephropathy flare-ups.
- Aimed at patients whose disease has not responded to standard steroid tablets.
- Treatment is given by a drip into a vein over a 6-month period.
- Total study involvement lasts around 46 weeks, including follow-up checks.
- Monitors whether the drug can protect kidneys and reduce protein in the urine.
Who may be eligible?
To take part in this study, you must be 18 years of age or older. The trial is open to both men and women.
You will need a confirmed diagnosis of primary IgA nephropathy and be experiencing an active flare-up of your condition. Most importantly, your flare must have shown little or no improvement after receiving standard steroid medicines.
The medical team will check your overall health and kidney function before you join. You may not be able to take part if you have certain other long-term illnesses, active infections, or if the trial team feels the study medicine would not be safe for 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.
- I am at least 18 years old.
- I have been diagnosed with IgA nephropathy.
- I am currently having a flare-up of kidney symptoms.
- Steroid treatment has not successfully brought my flare under control.
- I am able to attend regular hospital visits and complete 24-hour urine collections.
What does participation involve?
Taking part in this trial lasts for around 46 weeks (just under 11 months) in total. During the first 26 weeks, you will receive ravulizumab (Ultomiris) as an intravenous infusion—a liquid medicine given through a small needle and tube into a vein at a hospital clinic.
Throughout the study, you will have regular clinic visits. At these appointments, doctors will check your blood pressure, take blood samples to measure your kidney function, and ask you to collect your urine over a 24-hour period. These urine tests show how much protein and blood are leaking from your kidneys. After you complete the 26 weeks of treatment, you will stop the medicine but continue attending check-ups until week 46 so the team can monitor how your kidneys behave afterwards.
Potential risks and benefits
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Common questions
What is the main goal of this clinical trial?
The goal is to see if ravulizumab can safely reduce protein and blood leakage in the urine in patients whose kidney flares do not respond to steroids.
How is the study medicine given?
Ravulizumab is given as a drip into a vein (an intravenous infusion) at the hospital clinic.
How long will I receive the trial medicine?
You will receive the medicine for 26 weeks (about six months), followed by a 20-week monitoring period where you do not receive the drug.
What is a 24-hour urine collection?
It involves collecting all the urine you pass over a full 24-hour day in a special container so doctors can accurately measure how much protein and blood your kidneys are leaking.
Can I leave the study if I change my mind?
Yes. You can leave the study at any time and for any reason. Your usual medical care will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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