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Immunosuppressant

Rituximab combined with cyclosporine for Membranous Nephropathy

Phase 3
Recruiting
Led By Yan Qin, Doctor
Research Sponsored by Peking Union Medical College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3, 6, 9, 12, 18, 24 months
Awards & highlights

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).

Eligible Conditions
  • Membranous Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3, 6, 9, 12, 18, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3, 6, 9, 12, 18, 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
complete remission (CR) or partial remission (PR) at 24 month
Secondary outcome measures
Adverse events
Anti-PLA2R titer
Change of estimated glomerular filtration rate (eGFR)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rituximab combined with cyclosporineExperimental Treatment2 Interventions
Rituximab 1000mg I.V. on Days 1 and 181, and will be retreated or not on Days 15 and 195 according to CD19+ B cells count. cyclosporine (CsA) will be started at a dose of 3mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Doses of CsA will be adjusted according to the blood levels of CsA. CsA will be tapered after 6 months and discontinued over a 3 month period.
Group II: Rituximab monotherapyActive Control1 Intervention
Rituximab 1000mg I.V. on Days 1 and 181, and will be retreated or not on Days 15 and 195 according to the CD19+ B cells count.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Cyclosporine
FDA approved

Find a Location

Who is running the clinical trial?

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry Sponsor
14 Previous Clinical Trials
4,959 Total Patients Enrolled
Nanyang Nanshi Hospital of Henan UniversityUNKNOWN
Peking Union Medical College HospitalLead Sponsor
1,042 Previous Clinical Trials
2,204,165 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN
2021. "Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04743739.
~31 spots leftby May 2025
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