Omics of Rituximab-resistance

NCT07416942 | Not Yet Recruiting

• 1 other identifier: CONFUCIUS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Membranous Nephropathy

Keywords

membranous nephropathy; rituximab; B cells; pharmacogenetics; proteomics; metabolomics; scRNAseq

Outcome Measures

Primary Outcomes (1)

• Multiomics analyses

  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).

  At baseline and at 12 months after RTX treatment

Study Arms (3)

Sera samples of RTX-resistant patients

30 RTX-resistant patients (randomly selected among those with serum samples available)

Genetic: Multi-omics Analysis

Healthy volunteers

Healthy, age- and sex-matched subjects will be analysed as controls.

Genetic: Multi-omics Analysis; Procedure: Sample collection

Sera samples of RTX-responsive MN patients

30 RTX-responsive MN patients (matched for age, sex, baseline eGFR and proteinuria, and comorbidities with RTX-resistant MN)

Genetic: Multi-omics Analysis

Interventions

Multi-omics Analysis GENETIC

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

Healthy volunteers; Sera samples of RTX-resistant patients; Sera samples of RTX-responsive MN patients

Sample collection PROCEDURE

One single blood sample of approximately 25 ml.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient biological samples. The study will use samples collected from patients of the PROMENADE Study (NCT06242327) with a histologically confirmed diagnosis of MN, and who were treated with RTX. The samples, collected before and after RTX treatment, include DNA (n=300), sera (n=120), and peripheral blood mononuclear cells (PBMCs) (n=65), and are stored at the biobank of one of the IRFMN's site, the Clinical Research Center for Rare Diseases Aldo e Cele Daccò. Healthy volunteers: for comparison reasons, 60 volunteers, matched for age and sex, will also be analyzed.

You may qualify if:

• Adult patients
• Biopsy-proven primary membranous nephropathy (MN)
• Written informed consent for storage of biological samples in the local biobank

You may not qualify if:

• Absence of signed written informed consent for the storage of samples in the biobank
• Healthy subjects
• Adult male and female
• Written informed consent
• 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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Clinical Research Centre for Rare Diseases Aldo e Cele Daccò

Ranica, BG, 24020, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples i.e., DNA , sera, and PBMCs.

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Giuseppe Remuzzi, M.D.

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

Central Study Contacts

Marina Noris, Ph.D.

CONTACT

+390354535362; marina.noris@marionegri.it

Matias Trillini, M.D.

CONTACT

+390354535411; matias.trillini@marionegri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)