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Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous nephropathy - iRITUX
EU CTIS ID: 2024-510718-34-00
What this study is testing
To compare, in nephrotic rituximab-treated membranous nephropathy, the efficacy of a standard-of-care treatment versus a personalized treatment driven by the recommendation of the algorithm that predicts the risk of drug underexposure at month-3, in inducing clinical remission 6 months after rituximab treatment initiation.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Ongoing episode of membranous nephropathy diagnosed either by: the presence of anti-PLA2R1 or anti-THSD7A antibodies, or renal biopsy
- Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at screening
- Indication for rituximab treatment according to the KDIGO or French guidelines
- Non-immunosuppressive antiproteinuric treatment at stable dose for 2 weeks according to French guidelines, including a renin angiotensin aldosterone system inhibitor, a diuretic and a low-salt diet
- Estimated Glomerular Filtration Rate CKD-EPI > 30 mL/min/1,73 m²
You likely can't join if
- Secondary membranous nephropathy related to cancer, infection, systemic lupus, drug
- Patient refusing to follow the algorithm recommendation approved by their referring nephrologist
- Patient who, in the opinion of the investigator, cannot receive the treatment recommended by the iRITUX algorithm (safety or compliance reasons)
- Pregnancy or breastfeeding
- Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion
- Presence of anti-rituximab antibodies detected by Central Lab (if negative result available within 6 weeks before screening, or if the patient is naïve of rituximab treatment, the patient is eligible)
See the full eligibility criteria
- Age ≥ 18 years
- Ongoing episode of membranous nephropathy diagnosed either by: the presence of anti-PLA2R1 or anti-THSD7A antibodies, or renal biopsy
- Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at screening
- Indication for rituximab treatment according to the KDIGO or French guidelines
- Non-immunosuppressive antiproteinuric treatment at stable dose for 2 weeks according to French guidelines, including a renin angiotensin aldosterone system inhibitor, a diuretic and a low-salt diet
- Estimated Glomerular Filtration Rate CKD-EPI > 30 mL/min/1,73 m²
- Secondary membranous nephropathy related to cancer, infection, systemic lupus, drug
- Patient refusing to follow the algorithm recommendation approved by their referring nephrologist
- Patient who, in the opinion of the investigator, cannot receive the treatment recommended by the iRITUX algorithm (safety or compliance reasons)
- Pregnancy or breastfeeding
- Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion
- Presence of anti-rituximab antibodies detected by Central Lab (if negative result available within 6 weeks before screening, or if the patient is naïve of rituximab treatment, the patient is eligible)
- Cancer under treatment
- Patients with active, severe infections
- Hypersensitivity to the active substance or excipients
- Patients severely immunocompromised who, in the opinion of the investigator, cannot receive more than two 1-gram doses of rituximab
- Severe heart failure or severe, uncontrolled cardiac disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.