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Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN

NCT04743739 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-09

No results posted yet for this study

Summary

The primary objective of this study is to determine whether or not cyclosporine (CsA) combined with RTX is more effective than RTX alone in the treatment of idiopathic membranous nephropathy (iMN).

Conditions

  • Idiopathic Membranous Nephropathy

Interventions

DRUG

Rituximab

Rituximab 1000mg, I.V. on Days 1 and 181, and will be retreated or not at Days 15 and 195 according to the CD19+ B cell count.

DRUG

cyclosporine

cyclosporine (CsA) will be started at a dose of 3mg/kg/d and adjusted according to the blood levels of the CsA. CsA will be tapered after 6 months and discontinued over a three month period.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    collaborator OTHER

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • The Luhe Teaching Hospital of the Capital Medical University

    collaborator OTHER

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    collaborator OTHER

  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER

  • Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yan Qin, Doctor · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-12-20
Completion
2024-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04743739 on ClinicalTrials.gov