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

Sponsor
Shoichi Maruyama MD PhD
Study ID
NCT05914155
Phase
PHASE3
Status
Recruiting
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Conditions

  • Glomerulonephritis, Membranous
  • Nephrotic Syndrome，Idiopathic

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 24, 2023
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab group in double-blind phase
  • Placebo Comparator: Placebo group in double-blind phase
  • Other: Rituximab group in open-label phase

Primary Outcome Measure

Percentage of patients achieving ICR I [ Time Frame: up to 26 weeks ]

Central Contacts