NCT05914155

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

The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome （PRIME Study）

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Shoichi Maruyama MD PhD · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-06-24
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-06-22
• Last updated: 2025-02-11

Locations

18 sites across 1 country: Japan