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Clinical Trials in Italy / NCT07416942
Starting soon Observational

Omics of Rituximab-resistance

NCT07416942 · tracked via the Priya Life Science Italy tracker
Sponsor
Mario Negri Institute for Pharmacological Research
Phase
Observational
Started
2026-04
Last updated
2026-02-18

Condition(s) studied

Membranous Nephropathy

Investigational drug(s) / intervention(s)

Multi-omics AnalysisSample collection

Multi-omics Analysis: High-level molecular profiling (pharmacogenetics, proteomics, metabolomics, and scRNAseq) on patient samples

Sample collection: One single blood sample of approximately 25 ml.

Study summary

The CONFUCIUS project aims to establish a personalised medicine framework for MN patients by integrating pharmacogenomics with other -omics technologies in order to identify biomarkers that predict response to RTX, ultimately enabling optimized treatment selection. Using a multiomics approach, we will analyse genetic variants, serum and kidney proteomics, and serum metabolomics profiles from a well-characterised retrospective cohort of MN patients to uncover predictive biomarkers of RTX response.

This is a non-pharmacological interventional study, conducted on biological samples from patients stored in the local biobank and on samples from healthy volunteers, which will be collected and subsequently stored in the biobank.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Patients Inclusion Criteria: * Adult patients * Biopsy-proven primary membranous nephropathy (MN) * Written informed consent for storage of biological samples in the local biobank Exclusion Criteria: * Absence of signed written informed consent for the storage of samples in the biobank Healthy subjects Inclusion Criteria: * Adult male and female * Written informed consent Exclusion Criteria: * History of renal diseases, autoimmune disorders, diabetes mellitus, current allergies * Subjects who have taken antibiotics, anti-inflammatory drugs, or antihistamines within the past 7 days

Primary outcome measure(s)

  • Multiomics analyses — At baseline and at 12 months after RTX treatment
    Pharmacogenomic/multi-omics biomarkers predicting RTX response/resistance in MN (e.g., genetic variants in FCGR/FCGRT/C1QA/CD20/BAFF/IL-6, serum proteomics/metabolomics profiles, RTX-resistant immune cell signatures via scRNAseq/CITE-seq).

Trial sites (1)

FacilityCityRegionStatus
Clinical Research Centre for Rare Diseases Aldo e Cele Daccò Ranica BG

More Mario Negri Institute for Pharmacological Research trials in Italy

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Other trials for the same condition

An Outcome Analysis of Primary Membranous Nephropathy Recruiting
Autoreactive B Cells in Membranous Nephropathy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07416942 on ClinicalTrials.gov ↗ ← All trials in Italy