Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
NCT ID: NCT05914155
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
88 participants
INTERVENTIONAL
2023-06-24
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rituximab group in double-blind phase
Rituximab (genetical recombination)
Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.
Placebo group in double-blind phase
Placebo
Administer placebo IV infusion every two weeks for two doses in double-blind phase.
Rituximab group in open-label 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Patients who are diagnosed as having nephrotic syndrome prior to the obtainment of informed consent and receive no steroids or immunosuppressants within 12 weeks prior to the obtainment of informed consent
3. Patients with urine protein-creatinine ratio ≥ 3.5 g/gCr at the screening
4. Patients with hypoalbuminemia (serum albumin ≤ 3.0 g/dL) at the screening
5. Patients aged 15 years or older at informed consent
6. Patients who give voluntary written consent after having received adequate information on this study (legally acceptable representatives should also give consent for underage patients, and informed assent should be obtained from children)
Exclusion Criteria
2. Patients with the renal function lowered (eGFR \<30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening
3. Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent for idiopathic membranous nephropathy
4. Patients who have participated in another clinical study within 12 weeks prior to the informed consent (enrollment is allowed for those participating in a clinical study in the range of 'Indications' or 'Dosage and Administration' in Japan) or patients who are participating in another study
5. Patients with history of renal transplant
6. Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
7. Patients who have or are suspected to have active infection (infection requiring treatment with systemic antimicrobial, antifungal, or antiviral agents) at the time of informed consent
8. Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody (patients with positive HBs antibody and/or HBc antibody can be enrolled only when HBV-DNA test is negative \[less than the detection limit\]), or patients with positive HIV antibody or HTLV-1 antibody at the time of the screening
9. Patients with leukopenia (less than 2,000 /mm3), neutropenia (less than 1,000 /mm3), or lymphopenia (less than 500 /mm3) at the time of the screening
10. Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
11. Patients who are judged to be life-threatening nephrotic syndrome by the investigator or a subinvestigator
12. Patients with serious comorbidity (e.g., hepatic, renal (excluding idiopathic membranous nephropathy with nephrotic syndrome), cardiac, lung, hematologic, or brain disease)
13. Female patients who are pregnant, lactating, or potentially pregnant, patients who are not willing to use contraceptive measures during the study period, or female patients not willing to use contraceptive measures until 12 months after the last dose of study drug (except for female patients who are unale to pregnant)
14. Patients who are judged to be unsuitable by the investigator or a subinvestigator
15 Years
ALL
No
Sponsors
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Shoichi Maruyama MD PhD
OTHER
Responsible Party
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Shoichi Maruyama MD PhD
Professor
Principal Investigators
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Shoichi Shoichi, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Nagoya University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hideki Yokoi, PhD, MD
Role: primary
Shigenori Yamamoto, PhD, MD
Role: primary
Tasuku Nagasawa, PhD, MD
Role: primary
Tatsuo Tsukamoto, PhD, MD
Role: primary
Yoshitaka Isaka, PhD, MD
Role: primary
References
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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.
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.
Other Identifiers
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CAMCR-020
Identifier Type: -
Identifier Source: org_study_id
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