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New treatment option for Membranous Nephropathy
Official title Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)
ClinicalTrials.gov ID: NCT06341205
What this study is testing
What is RiTUXimab Injection?
RiTUXimab Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for membranous nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Ongoing episode of membranous nephropathy diagnosed by the presence of anti-PLA2R1 antibodies detected by ELISA (≥ 14 RU/ml, EUROIMMUN): the result...
- Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis
- Estimated Glomerular Filtration Rate (CKD-EPI formula) \> 30 mL/min/1,73 m2
- Indication for rituximab treatment according to the KDIGO and French guidelines
You likely can't join if
- Secondary Membranous nephropathy related to cancer, infection, systemic lupus, drug
- Diagnosis of PLA2R1-associated Membranous nephropathy not confirmed by the Coordination team (validation mandatory for randomization)
- Pregnancy or breastfeeding
- Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion
- Presence of anti-rituximab antibodies detected by Central Lab
- Cancer under treatment
See the full eligibility criteria
- Age ≥ 18 years
- Ongoing episode of membranous nephropathy diagnosed by the presence of anti-PLA2R1 antibodies detected by ELISA (≥ 14 RU/ml, EUROIMMUN): the result must be validated by the Coordination team before randomization.
- Nephrotic syndrome defined by proteinuria \> 3.5 g/24h (or UPCR \> 3.5 g/g) and serum albumin \< 30 g/L at diagnosis
- Estimated Glomerular Filtration Rate (CKD-EPI formula) \> 30 mL/min/1,73 m2
- Indication for rituximab treatment according to the KDIGO and 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 at maximal tolerated...
- Secondary Membranous nephropathy related to cancer, infection, systemic lupus, drug
- Diagnosis of PLA2R1-associated Membranous nephropathy not confirmed by the Coordination team (validation mandatory for randomization)
- Pregnancy or breastfeeding
- Immunosuppressive treatment (including rituximab) in the 6 months preceding inclusion
- Presence of anti-rituximab antibodies detected by Central Lab
- Cancer under treatment
- Patients with active, severe infections
- Hypersensitivity to the active substance or excipients
- Patients severely immunocompromised
- Severe heart failure or severe, uncontrolled cardiac disease
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Caen, France
- Créteil, France
- Lyon, France
- Marseille, France
- Nice, France
- Nîmes, France
- Paris, France
- Toulouse, France
- Tours, France
- Valenciennes, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Caen, France; Créteil, France; Lyon, France; Marseille, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.