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NCT06341205 | RECRUITING | Membranous Nephropathy

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

Nice University Hospital Center

Brief Summary:

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. The identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why rituximab regimen with low dose infusions (375 mg/m2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months. Recently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3. Nowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions. The objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk.

Condition or disease

Membranous Nephropathy

Intervention/treatment

RiTUXimab Injection

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous Nephropathy
Actual Study Start Date : 2025-02-04
Estimated Primary Completion Date : 2031-08-31
Estimated Study Completion Date : 2031-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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 dose (i.e., absence of orthostatic hypotension and no increase in creatinine \> 30%)
Exclusion Criteria
  • * 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
Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)

Location Details

NCT06341205

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France,

CHU of BESANCON

Besançon, France,

RECRUITING

France,

BORDEAUX University Hospital - Pellegrin Hospital

Bordeaux, France,

RECRUITING

France,

chu's CAE N

Caen, France,

RECRUITING

France,

AP-HP - H. Mondor Hospital

Creteil, France,

RECRUITING

France,

HCL - E. Herriot Hospital

Lyon, France,

RECRUITING

France,

AP-HM - Conception Hospital

Marseille, France,

RECRUITING

France,

chu's nice

Nice, France,

RECRUITING

France,

Nîmes University Hospital - CAREMEAU Hospital

Nimes, France,

NOT YET RECRUITING

France,

AP-HP - Georges Pompidou European Hospital

Paris, France,

NOT YET RECRUITING

France,

AP-HP - Hôpital Necker

Paris, France,

RECRUITING

France,

TOULOUSE University Hospital - Rangueil Hospital

Toulouse, France,

RECRUITING

France,

TOURS CHRU - Bretonneau Hospital

Tours, France,

NOT YET RECRUITING

France,

Valenciennes CH

Valenciennes, France,