A Phase 3 open-label, controlled, randomised, multi-centre trial comparing imlifidase and standard-of-care with standard-of-care alone in the treatment of severe anti-GBM antibody disease (Goodpasture disease)
This research is looking into a new treatment called Idefirix for a serious and rare kidney condition known as Goodpasture disease (also called anti-GBM antibody disease). Patients taking part will be randomly assigned to two groups. One group will receive Idefirix alongside the standard treatments currently used for this condition. The other group will receive the standard treatments only. The main goal is to find out if Idefirix can help improve how well the kidneys work after six months compared to standard care alone. The study will also look at other important things like maintaining kidney function and how the new treatment affects the disease over time.
At a glance
What is this study about?
Goodpasture disease is a very rare but serious condition where your body's immune system mistakenly attacks your kidneys and sometimes your lungs. This can cause severe damage that might lead to kidney failure.
Doctors are always looking for better ways to treat conditions like Goodpasture disease. This study is testing a new medication called Idefirix. The main idea behind Idefirix is to quickly remove harmful substances (called antibodies) from your blood that are attacking your kidneys. This study aims to see if adding Idefirix to the usual treatments (like steroids and other immune-suppressing medicines) can help protect your kidneys more effectively.
Participants will be split into different groups by chance. This allows doctors to fairly compare the new treatment with existing ones. The study wants to understand if Idefirix can improve how well your kidneys work and if it can help prevent the need for dialysis or reduce other complications from the disease over a six-month period.
Key takeaways
- This study investigates a new treatment (Idefirix) for Goodpasture disease.
- It aims to see if Idefirix improves kidney function better than usual care.
- Participants will be randomly assigned to receive either the new drug or standard care.
- The study tracks kidney health, antibody levels, and quality of life over six months.
- It's for adults 18 years and older with severe Goodpasture disease.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older. The study is open to both men and women.
All participants must have been recently diagnosed with severe Goodpasture disease (anti-GBM antibody disease).
There will be other medical checks and criteria that the study doctors will go through with you to make sure this study is safe and right for your specific health situation.
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 recently been diagnosed with severe Goodpasture disease?
- Are you able to attend regular hospital visits for assessments?
- Are you comfortable with the idea of possibly receiving a new, untested treatment?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive the new medicine, Idefirix, in addition to standard treatments (like prednisolone, cyclophosphamide, and methylprednisolone). The other group will receive standard treatments only.
You'll have regular visits to the hospital or clinic for blood tests (to check kidney function, antibody levels, and medicine levels), urine tests, and general health checks. Some assessments will measure your kidney function, while others will involve questionnaires about your quality of life. The study will also track any treatments like dialysis you might need.
The main part of the study will last for six months. During this time, your health will be carefully monitored. After this period, you will continue to be followed up for some aspects of your health.
Potential risks and benefits
Locations (12)
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedSweden
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedBelgium
- —UnverifiedDenmark
- —UnverifiedIreland
- —UnverifiedPoland
Common questions
What is Goodpasture disease?
It's a rare condition where your immune system attacks your kidneys, and sometimes your lungs, causing damage.
What is Idefirix?
Idefirix is a new medicine being tested to help remove harmful antibodies that damage kidneys in Goodpasture disease.
Will I definitely get the new medicine?
No, you will be randomly assigned to either receive Idefirix plus usual care, or usual care alone.
How long will the study last for me?
The main treatment and assessment period for the study will be six months, with some follow-up beyond that.
What does 'standard-of-care' mean?
It refers to the usual treatments that doctors currently use for Goodpasture disease.
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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