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RECRUITING
NCT05914155
PHASE3

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

Sponsor: Shoichi Maruyama MD PhD

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2023-06-24

Completion Date

2027-12-31

Last Updated

2025-02-11

Healthy Volunteers

No

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.

Locations (18)

Anjo Kosei Hospital

Anjo, Aichi-ken, Japan

Kasugai Municipal Hospital

Kasugai, Aichi-ken, Japan

Konan Kosei Hospital

Kōnan, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University hospital

Toyoake, Aichi-ken, Japan

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospial

Kurume, Fukuoka, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Mie University Hospial

Tsu, Mie-ken, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Tazuke Kofukai, Medical Research Institute, Kitano Hospital

Osaka, Osaka, Japan

Osaka University Hospital

Osaka, Osaka, Japan

Hamamatsu University Hosptial

Hamamatsu, Shizuoka, Japan