MedTrace Logo

A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy

NCT05824390 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-04-21

No results posted yet for this study

Summary

A study to evaluate safety and activity in treatment of IgAN patients using Rituximab in combination with RASi(ACEI and/or ARB) compared with RASi.

Conditions

Interventions

DRUG

rituximab group

Rituximab is a human-mouse chimeric monoclonal antibody specifically targeting B cell surface antigen CD20. CD20 may act as a calcium channel to play a certain signal role and participate in the regulation of B cell maturation and differentiation. Once combined with CD20, RTX consumed CD20 + B fines through antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity and direct induction of apoptosis. Recent studies have shown that B cell depletion therapy has a certain effect on many autoantibodies-mediated kidney diseases ( such as membranous nephropathy, lupus nephritis, etc. ). Therefore, rituximab combined with CD20 antigen on the surface of B cells can exhaust B cells that produce antibodies and play a therapeutic role by reducing antibody production, so this therapy also has potential therapeutic value for IgAN patients.

Sponsors & Collaborators

  • Dongfang Hospital Affiliated to Tongji University

    collaborator OTHER

  • Shanghai Pudong New Area People's Hospital

    collaborator OTHER

  • Ruijin Hospital North Shanghai Jiao Tong University School of Medicine

    collaborator UNKNOWN

  • Ningbo Municipal Yinzhou District No.2 Hospital

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Xiamen Humanity Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • XIEJINGYUAN

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05824390 on ClinicalTrials.gov