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Active, not recruiting Phase 3

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

NCT05914155 · tracked via the Priya Life Science Japan tracker
Sponsor
Shoichi Maruyama MD PhD
Phase
Phase 3
Started
2023-06-24
Last updated
2026-08-12

Condition(s) studied

Glomerulonephritis, MembranousNephrotic Syndrome,Idiopathic

Investigational drug(s) / intervention(s)

Rituximab (genetical recombination) →PlaceboRituximab (genetical recombination) →

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.

Study summary

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

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent 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: 1. Patients with primary nephrotic syndrome other than membranous nephropathy (IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis and so forth), and patients with secondary nephrotic syndrome (autoimmune disease, metabolic disease, infection, allergic/hypersensitive disease, tumor, and drug-induced disease) 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

Primary outcome measure(s)

  • Percentage of patients achieving ICR I — up to 26 weeks
    Achieving ICR I is defined as "Urine protein-creatinine ratio \< 1.0 g/gCr".

Trial sites (18)

FacilityCityRegionStatus
Anjo Kosei Hospital Anjo Aichi-ken
Kasugai Municipal Hospital Kasugai Aichi-ken
Konan Kosei Hospital Kōnan Aichi-ken
Nagoya University Hospital Nagoya Aichi-ken
Fujita Health University hospital Toyoake Aichi-ken
Juntendo University Urayasu Hospital Urayasu Chiba
Kyushu University Hospital Fukuoka Fukuoka
Kurume University Hospial Kurume Fukuoka
Asahikawa Medical University Hospital Asahikawa Hokkaido
Kanazawa University Hospital Kanazawa Ishikawa-ken
Kumamoto University Hospital Kumamoto Kumamoto
University Hospital,Kyoto Prefectural University of Medicine Kyoto Kyoto
Kyoto University Hospital Kyoto Kyoto
Mie University Hospial Tsu Mie-ken
Tohoku University Hospital Sendai Miyagi
Tazuke Kofukai, Medical Research Institute, Kitano Hospital Osaka Osaka
Osaka University Hospital Osaka Osaka
Hamamatsu University Hosptial Hamamatsu Shizuoka
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05914155 on ClinicalTrials.gov ↗ ← All trials in Japan