Obinutuzumab for primary membranous nephropathy: a pilot study in patients with rituximab-resistant or rituximab-dependent nephrotic syndrome and in patients intolerant to rituximab (the ORION study)
This study, called ORION, is testing a new treatment called Obinutuzumab for a kidney condition called primary membranous nephropathy. This condition affects the filters in your kidneys, leading to problems like swelling. We're focusing on patients who haven't improved with the usual treatment, rituximab, or those who can't take rituximab. The main goals are to see how many people go into remission (their symptoms get much better or disappear) after 12 months with Obinutuzumab, and to monitor for any side effects. This is a Phase II study, meaning we're exploring if the treatment is effective and safe in a smaller group of people. We'll also look at longer-term effects after 6 and 24 months, and check how the drug affects other kidney health markers.
At a glance
What is this study about?
This study is called the ORION study, and it's looking into a new treatment for a kidney disease called primary membranous nephropathy. In this condition, the tiny filters in your kidneys (called glomeruli) become damaged, which can lead to too much protein leaking into your urine, causing swelling and other issues.
The drug being tested is called Obinutuzumab (you might hear it called Gazyvaro). This study is specifically for people whose condition hasn't responded well to a common treatment called rituximab, or for those who can't take rituximab due to side effects or other reasons. The researchers want to find out how effective Obinutuzumab is at helping patients go into 'remission', which means their kidney disease symptoms get much better or even disappear completely.
This is a Phase II study, which means it's still in the earlier stages of testing. The main things the doctors will be looking at are whether Obinutuzumab helps people achieve complete or partial remission of their kidney problems after 12 months, and importantly, to keep a close eye on any side effects or reactions to the treatment. They'll also follow people for longer to see how they're doing after 6 and 24 months, and check various other health markers related to kidney function.
Key takeaways
- This study is for a specific kidney disease called primary membranous nephropathy.
- It's testing a new drug, Obinutuzumab, for people who haven't responded to rituximab or can't take it.
- The main goals are to see if the new drug helps improve the kidney condition and if it's safe.
- Taking part involves regular check-ups and monitoring for at least two years.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, people must be 18 years old or older. The study is open to both men and women.
Crucially, participants must have primary membranous nephropathy. This study is specially designed for those who haven't responded well to previous treatment with rituximab, or those who found rituximab caused problems and couldn't continue taking it. This means the study is looking for people whose kidney condition is proving difficult to manage with standard treatments.
Your doctor will discuss all the detailed requirements with you to make sure the study is a good and safe fit for your particular 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 over?
- Have you been diagnosed with primary membranous nephropathy?
- Has your condition not responded well to rituximab, or have you had problems taking rituximab?
- Are you able to attend regular hospital visits for tests and monitoring?
What does participation involve?
If you decide to take part, you'll receive the study drug, Obinutuzumab (Gazyvaro), which is given as an infusion into your vein. You might also receive other common medications like pain relief (TACHIPIRINA) or steroid tablets (MEDROL, CORTRIUM) if needed to manage any symptoms or side effects. The study will last for at least 24 months (two years) in total.
Throughout the study, you'll have regular hospital visits for check-ups. These visits will involve blood tests to see how your kidneys are working, measure protein levels, check your immune system cells, and monitor for any side effects. You'll also have urine tests to see how much protein is being lost. The doctors will closely monitor your general health and how well the treatment is working. This close monitoring is very important to keep you safe and collect valuable information.
Potential risks and benefits
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Common questions
What is primary membranous nephropathy?
It's a kidney disease where the tiny filters in your kidneys get damaged, causing protein to leak into your urine, which can lead to swelling and other problems.
Why is this study looking at Obinutuzumab?
It’s being tested as a possible new treatment for people whose kidney disease hasn't improved with standard care (rituximab) or for those who can't take rituximab.
What does 'remission' mean in this study?
It means your kidney disease symptoms significantly improve or completely disappear, and tests show better kidney function.
What are the main things being checked in this study?
The study is mainly checking how well Obinutuzumab helps people go into remission, and carefully monitoring for any side effects.
How long will I be followed if I join?
You will be followed by the study team for at least 24 months (two years) to see how you are doing with the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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