RecruitingPHASE3INTERVENTIONAL

Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)

This study, called iRITUX, focuses on membranous nephropathy, a kidney condition where the body's immune system attacks its own kidney filters. It's the most common cause of a problem called nephrotic syndrome in many adults. While a medication called rituximab often helps, some people don't respond well. This might be because the medicine leaves the body too quickly through the kidneys. Researchers found that if enough rituximab stays in the blood, patients are more likely to get better. This study will use special computer programs (AI) to predict which patients might not have enough rituximab in their system. For these patients, the study will offer earlier, extra doses of rituximab, aiming to make the treatment more effective and personalised.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

120

Start

04 Feb 2025

Estimated completion

30 Sep 2031

Membranous Nephropathy

What is this study about?

Membranous nephropathy is a condition where the tiny filters in your kidneys get damaged by your body's own immune system. This can lead to your kidneys leaking too much protein into your urine, a problem called nephrotic syndrome. It's a common cause of kidney problems in many adults, and how it affects each person can be very different – some get better on their own, while for others, it can lead to more serious kidney disease over time.

One common and effective treatment for this condition is a medicine called rituximab. However, we know that up to 40% of people don't respond well to their first course of this treatment. Researchers think this might be because patients with kidney problems lose some of the rituximab through their urine, meaning not enough of the medicine stays in their blood to do its job properly. Studies have shown that when there's a good level of rituximab in the blood after treatment, patients are more likely to get better.

This new study, called iRITUX, wants to make rituximab treatment even better and more personal. Scientists are using advanced computer programs, known as artificial intelligence (AI), to predict which patients might be at risk of not having enough rituximab in their blood three months after their first treatment. For these patients, the study will try giving extra doses of rituximab earlier than usual. The main goal is to see if this personalised approach, guided by AI, can help more people respond well to treatment and protect their kidneys.

Key takeaways

Targets membranous nephropathy, a kidney condition.
Uses a common medicine called rituximab.
Aims for more effective treatment by personalising rituximab doses.
Uses artificial intelligence (AI) to guide treatment decisions.
Could help more patients respond better to therapy.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with membranous nephropathy through a specific blood test showing certain antibodies (anti-PLA2R1). Your kidneys must also be leaking a significant amount of protein (nephrotic syndrome), and your kidney function should still be at a certain level.

You also need to be a candidate for rituximab treatment as guided by current medical recommendations, and already be on stable supportive kidney medication for at least two weeks. This includes specific blood pressure medicines, water tablets (diuretics), and a low-salt diet.

There are also reasons you couldn't join. For example, if your membranous nephropathy is caused by something else like cancer or another serious illness, or if you are pregnant or breastfeeding. You also can't have had rituximab or other similar immune-suppressing treatments in the last six months, or have certain other medical conditions like severe infections, active cancer, severe heart failure, or a known allergy to rituximab.

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 membranous nephropathy confirmed by a specific blood test?
Are your kidneys losing a lot of protein (nephrotic syndrome)?
Is your current kidney function still at a certain level (not too low)?
Are you a suitable candidate for rituximab treatment?
Have you been on stable kidney-supportive medication for at least two weeks?

Answer every question to see your result.

What does participation involve?

If you join the iRITUX study, you will receive rituximab injections. The main difference will be that a computer program will help decide if you need extra doses of rituximab earlier than usual, based on your blood levels of the medicine. You will have regular appointments where blood tests and urine tests will be taken to check how you are responding and to monitor the medicine levels. Researchers will also check your overall health and kidney function regularly.

The study will involve several visits to the hospital or clinic for these checks and treatments. The exact number and frequency of visits will be explained by the study team, but they will likely be more frequent at the beginning and then spread out over time. You'll need to continue your usual supportive kidney medications as part of the study. The total duration of your participation in the study, including follow-up, will be explained in full by the study team.

Potential risks and benefits

Taking part in this study could potentially offer a more personalised and effective treatment for your membranous nephropathy, as the aim is to improve how well rituximab works. However, as with any medical treatment, there are potential risks and side effects from rituximab, including allergic reactions or increased risk of infections. The medical team will explain all known side effects. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

CHU de BESANCON
Verified postcode
Besançon, France· Recruiting
CHU de BORDEAUX - Hôpital Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CHU de CAEN
Verified postcode
Caen, France· Recruiting
AP-HP - Hôpital H. Mondor
Verified postcode
Créteil, France· Recruiting
HCL - Hôpital E. Herriot
Verified postcode
Lyon, France· Recruiting
AP-HM - Hôpital de la Conception
Verified postcode
Marseille, France· Recruiting
CHU de NICE
Verified postcode
Nice, France· Recruiting
CHU de Nîmes - Hôpital CAREMEAU
Verified postcode
Nîmes, France· Recruiting
AP-HP - Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Not yet recruiting
AP-HP - Hôpital Necker
Verified postcode
Paris, France· Not yet recruiting
CHU de TOULOUSE - Hôpital Rangueil
Verified postcode
Toulouse, France· Recruiting
CHRU de TOURS - Hôpital Bretonneau
Verified postcode
Tours, France· Recruiting

Common questions

What is membranous nephropathy?

It's a kidney disease where the kidney's filters get damaged, causing them to leak too much protein into your urine.

What is rituximab?

It's a medicine often used for immune system conditions, including membranous nephropathy, to help control the body's immune response.

What is artificial intelligence (AI) used for in this study?

AI helps predict if you might need extra doses of rituximab earlier to make sure the treatment is more effective for you.

Will I get personalised treatment?

Yes, if the AI predicts you're at risk of not having enough medicine in your system, you could receive early extra doses of rituximab.

Are there any extra tests needed for the study?

You will have regular blood and urine tests to monitor your health and the levels of the medicine in your body.

How to find out more

Barbara SEITZ-POLSKI, MD, PhD

seitz-polski.b@chu-nice.fr +33492038828 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.