Can a single Immune-Targeting drug quiet an autoimmune kidney disease?
NCT ID NCT05914155
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether rituximab, an infusion drug that calms certain immune cells, can help people with idiopathic membranous nephropathy and nephrotic syndrome. Participants receive either rituximab or a placebo, and the study tracks how many achieve a significant reduction in urine protein, a key sign of kidney improvement. The goal is to see if this treatment can offer a safer, steroid-free way to manage the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab (an infusion drug that targets certain immune cells)
- What this could lead to
- If successful, rituximab could become a steroid-free option to help people with this kidney disease achieve remission and avoid progression to kidney failure.
- What could go wrong
- This is a phase 3 trial, but results are not guaranteed. Rituximab can have side effects like infusion reactions and increased infection risk, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anjo Kosei Hospital
Anjo, Aichi-ken, 4468602, Japan
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Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 0788510, Japan
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Fujita Health University hospital
Toyoake, Aichi-ken, 4701192, Japan
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Hamamatsu University Hosptial
Hamamatsu, Shizuoka, 4313129, Japan
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Juntendo University Urayasu Hospital
Urayasu, Chiba, 2790021, Japan
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Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 9208641, Japan
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Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510, Japan
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Konan Kosei Hospital
Kōnan, Aichi-ken, 4838704, Japan
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Kumamoto University Hospital
Kumamoto, Kumamoto, 8608556, Japan
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Kurume University Hospial
Kurume, Fukuoka, 8300011, Japan
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Kyoto University Hospital
Kyoto, Kyoto, 6068507, Japan
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Kyushu University Hospital
Fukuoka, Fukuoka, 8128582, Japan
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Mie University Hospial
Tsu, Mie-ken, 5148507, Japan
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Nagoya University Hospital
Nagoya, Aichi-ken, 4668560, Japan
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Osaka University Hospital
Osaka, Osaka, 5650871, Japan
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Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Osaka, Osaka, 5308480, Japan
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Tohoku University Hospital
Sendai, Miyagi, 9808574, Japan
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University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 6028566, Japan
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