Omics of Rituximab-resistance
ConditionMembranous Nephropathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Adult patients
Biopsy-proven primary membranous nephropathy (MN)
Written informed consent for storage of biological samples in the local biobank
Disqualifiers
Absence of signed written informed consent for the storage of samples in the biobank
Adult male and female
Written informed consent
History of renal diseases, autoimmune disorders, diabetes mellitus, current allergies
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multi-omics Analysis
GeneticHigh-level molecular profiling (pharmacogenetics, proteomics, metabolomics, and scRNAseq) on patient samples
Sample collection
Procedure/SurgeryOne single blood sample of approximately 25 ml.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Sera samples of RTX-resistant patients1 intervention
Group B: Healthy volunteers2 interventions
Group C: Sera samples of RTX-responsive MN patients1 intervention
Trial outcomes
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).
Time frame
At baseline and at 12 months after RTX treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: