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To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab group in double-blind phase | Active Comparator |
| |
| Placebo group in double-blind phase | Placebo Comparator |
| |
| Rituximab group in open-label phase | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab (genetical recombination) | Drug | Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving ICR I | Achieving ICR I is defined as "Urine protein-creatinine ratio < 1.0 g/gCr". | up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who are CR, ICR I, ICR II, NR or PR | CR, ICR I, ICR II, NR or PR are defied as below; CR (Complete Remission): Urine protein-creatinine ratio < 0.3 g/gCr ICR I (Incomplete Remission Type I): 0.3 g/gCr ≤ Urine protein-creatinine ratio < 1.0 g/gCr ICR II (Incomplete Remission Type II): 1.0 g/gCr ≤ Urine protein-creatinine ratio < 3.5 g/gCr NR (No Response): 3.5 g/gCr ≤ Urine protein-creatinine ratio PR (Partial Remission): Decrease in urine protein-creatinine ratio from base line ≥50%, and urine protein-creatinine ratio 0.3 to 3.5 g/gCr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shoichi Maruyama, PhD, MD | Contact | +81527442192 | marus@med.nagoya-u.ac.jp | |
| Shinobu Shimizu, PhD | Contact | +81527442942 | shimizu.shinobu.w3@f.mail.nagoya-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Shoichi Shoichi, PhD, MD | Nagoya University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjo Kosei Hospital | Recruiting | Anjo | Aichi-ken | 4468602 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40100934 | Derived | Shimizu S, Tanaka A, Matsuyama N, Kinoshita F, Furuhashi K, Maruyama S; PRIME Study Group. Randomised, double-blind study to evaluate the efficacy of rituximab in the treatment of idiopathic membranous nephropathy: A clinical trial protocol. PLoS One. 2025 Mar 18;20(3):e0320070. doi: 10.1371/journal.pone.0320070. eCollection 2025. | |
| 39513526 |
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If the principal investigator, clinical trial office, main stakeholder conclude that secondary use of individual data obtained in this clinical trial is beneficial for additional analysis, the secondary use of data excluding personal information will be acceptable after publication of results.
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| 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. |
|
| up to 26 weeks |
| Duration before achieving CR, ICR I, ICR II or PR | Duration of achieving CR, ICR I, ICR II or PR is summarized. | up to 26 weeks |
| Urine protein-creatinine ratio | The differences of urine protein-creatinine ratio between prior to treatment and at each timepoint are summarized. | up to 26 weeks |
| eGFR | The differences of eGFR between prior to treatment and at each timepoint are summarized. | up to 26 weeks |
| B-cells (CD19-positive and CD20-positive cells) | B cell counts (CD19 positive and CD20 positive cell counts) at each timepoint are summarized. | up to 26 weeks |
| Expression of HACA | The number of patients expressing HACA, and the proportion of these patients at each timepoint are summarized. | up to 26 weeks |
| Serum rituximab (genetical recombination) concentration | Serum rituximab (genetical recombination) level at each timepoint are summarized. | up to 26 weeks |
| Kasugai Municipal Hospital | Recruiting | Kasugai | Aichi-ken | 486-8510 | Japan |
|
| Konan Kosei Hospital | Recruiting | Kōnan | Aichi-ken | 4838704 | Japan |
|
| Nagoya University Hospital | Recruiting | Nagoya | Aichi-ken | 4668560 | Japan |
|
| Fujita Health University hospital | Recruiting | Toyoake | Aichi-ken | 4701192 | Japan |
|
| Juntendo University Urayasu Hospital | Recruiting | Urayasu | Chiba | 2790021 | Japan |
|
| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | 8128582 | Japan |
|
| Kurume University Hospial | Recruiting | Kurume | Fukuoka | 8300011 | Japan |
|
| Asahikawa Medical University Hospital | Recruiting | Asahikawa | Hokkaido | 0788510 | Japan |
|
| Kanazawa University Hospital | Recruiting | Kanazawa | Ishikawa-ken | 9208641 | Japan |
|
| Kumamoto University Hospital | Recruiting | Kumamoto | Kumamoto | 8608556 | Japan |
|
| University Hospital,Kyoto Prefectural University of Medicine | Recruiting | Kyoto | Kyoto | 6028566 | Japan |
|
| Kyoto University Hospital | Recruiting | Kyoto | Kyoto | 6068507 | Japan |
|
| Mie University Hospial | Recruiting | Tsu | Mie-ken | 5148507 | Japan |
|
| Tohoku University Hospital | Recruiting | Sendai | Miyagi | 9808574 | Japan |
|
| Tazuke Kofukai, Medical Research Institute, Kitano Hospital | Recruiting | Osaka | Osaka | 5308480 | Japan |
|
| Osaka University Hospital | Recruiting | Osaka | Osaka | 5650871 | Japan |
|
| Hamamatsu University Hosptial | Recruiting | Hamamatsu | Shizuoka | 4313129 | Japan |
|
| Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6. |
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| D009402 | Nephrosis, Lipoid |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009401 | Nephrosis |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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