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Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
Sponsor: Shoichi Maruyama MD PhD
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
Rituximab (genetical recombination)
Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.
Placebo
Administer placebo IV infusion every two weeks for two doses in double-blind phase.
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