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B Cells in Idiopathic Nephrotic Syndrome

NCT05712369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-11-29

No results posted yet for this study

Summary

The main aim of the present study is to determine whether reconstitution of different B-cell subpopulations can predict relapse after treatment with B-cell depleting antibodies in adult with NS, and whether specific B- or T-cell anomalies (as well as dysregulation of other circulating immune cell subsets) may play a role in the disease pathogenesis of SDNS and FRNS.

Conditions

  • Nephrotic Syndrome

Interventions

OTHER

Blood sampling

Before the anti-CD20 monoclonal antibodies treatment (e.g. Rituximab/Ofatumumab) and after 6, 9 and 12, 24 months from the first infusion the following blood samples will be collected for the analysis of lymphocyte subpopulations: * 50/100 mL of blood (20 mL for pediatric patients) for Peripheral Blood Mononuclear Cells (PBMCs) isolation. * 8 mL of blood (both adult and pediatric) to obtain serum. Serum will be obtained by standard centrifugation and PBMC will be isolated by Ficoll-Paque® density gradient centrifugation, according to manufacturer's instruction.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, MD · Istituto Di Ricerche Farmacologiche Mario Negri

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2024-11-07
Completion
2024-11-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712369 on ClinicalTrials.gov