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Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome

NCT05914155 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-02-11

No results posted yet for this study

Summary

To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.

Conditions

  • Glomerulonephritis, Membranous
  • Nephrotic Syndrome，Idiopathic

Interventions

DRUG

Rituximab (genetical recombination)

Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.

DRUG

Placebo

Administer placebo IV infusion every two weeks for two doses in double-blind phase.

DRUG

Rituximab (genetical recombination)

Patients who remain to be ICR II (Incomplete Remission Type II) or NR (No Response) until Week 26 in the double-blind phase, if the patients wish to move to the open-label phase and the investigator or a subinvestigator considers the move necessary, the patient will move to the open-label phase and receive 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses after the readministration criteria are confirmed to be met.

Sponsors & Collaborators

  • Shoichi Maruyama MD PhD

    lead OTHER

Principal Investigators

  • Shoichi Shoichi, PhD, MD · Nagoya University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-24
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Japan

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 NCT05914155 on ClinicalTrials.gov