Artificial intelligence-based personalised rituximab treatment protocol in membranous nephropathy (iRITUX): protocol for a multicentre randomised control trial.

Journal: BMJ open
PMID:

Abstract

INTRODUCTION: Membranous nephropathy is an autoimmune kidney disease and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. Rituximab is now recommended as first-line therapy for membranous nephropathy. However, Kidney Disease Improving Global Outcomes guidelines do not recommend any specific protocol. Rituximab bioavailability is reduced in patients with membranous nephropathy due to urinary drug loss. Underdosing of rituximab is associated with treatment failure. We have previously developed a machine learning algorithm to predict the risk of underdosing. We have retrospectively shown that patients with a high risk of underdosing required higher doses of rituximab to achieve remission. The aim of this prospective study is to evaluate the efficacy of algorithm-driven rituximab treatment in patients with membranous nephropathy compared to standard treatment.

Authors

  • Maxime Teisseyre
    Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, CHU de Nice, Université Côte d'Azur, France.
  • Alexandre Destere
    Département de Pharmacologie et de Pharmacovigilance, CHU de Nice, Université Côte d'Azur, France.
  • Marion Cremoni
    Unité de Recherche Clinique Côte d'Azur (UR2CA), Université Côte d'Azur, CHU de Nice, France.
  • Kévin Zorzi
    Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, CHU de Nice, Université Côte d'Azur, France.
  • Vesna Brglez
    Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, CHU de Nice, Université Côte d'Azur, France.
  • Sylvain Benito
    EXACTCURE, Nice, France.
  • Laurent Bailly
    Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, Provence-Alpes-Côte d'Azur, France.
  • Céline Fernandez
    Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, CHU de Nice, Université Côte d'Azur, France.
  • Barbara Seitz-Polski
    Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, CHU de Nice, Université Côte d'Azur, France.