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New treatment option for Glomerulonephritis, Membranous
Official title Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
ClinicalTrials.gov ID: NCT05914155
What this study is testing
What is Rituximab (genetical recombination)?
Rituximab (genetical recombination) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glomerulonephritis, membranous.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent
- Patients who are diagnosed as having nephrotic syndrome prior to the obtainment of informed consent and receive no steroids or immunosuppressants...
- Patients with urine protein-creatinine ratio ≥ 3.5 g/gCr at the screening
- Patients with hypoalbuminemia (serum albumin ≤ 3.0 g/dL) at the screening
- Patients aged 15 years or older at informed consent
You likely can't join if
- Patients with primary nephrotic syndrome other than membranous nephropathy (IgA nephropathy, minimal change disease, focal segmental...
- Patients with the renal function lowered (eGFR \<30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening
- Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent for idiopathic membranous...
- Patients who have participated in another clinical study within 12 weeks prior to the informed consent (enrollment is allowed for those participating...
- Patients with history of renal transplant
- Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
See the full eligibility criteria
- Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent
- 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
- Patients with urine protein-creatinine ratio ≥ 3.5 g/gCr at the screening
- Patients with hypoalbuminemia (serum albumin ≤ 3.0 g/dL) at the screening
- Patients aged 15 years or older at informed consent
- 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...
- 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...
- Patients with the renal function lowered (eGFR \<30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening
- Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent for idiopathic membranous nephropathy
- 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...
- Patients with history of renal transplant
- Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
- 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
- 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...
- 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
- Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
- Patients who are judged to be life-threatening nephrotic syndrome by the investigator or a subinvestigator
- Patients with serious comorbidity (e.g., hepatic, renal (excluding idiopathic membranous nephropathy with nephrotic syndrome), cardiac, lung, hematologic, or brain disease)
- 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...
- Patients who are judged to be unsuitable by the investigator or a subinvestigator
The study team makes the final eligibility decision.
Where it's taking place
- Anjo, Aichi-ken, Japan
- Kasugai, Aichi-ken, Japan
- Kōnan, Aichi-ken, Japan
- Nagoya, Aichi-ken, Japan
- Toyoake, Aichi-ken, Japan
- Urayasu, Chiba, Japan
- Fukuoka, Fukuoka, Japan
- Kurume, Fukuoka, Japan
- Asahikawa, Hokkaido, Japan
- Kanazawa, Ishikawa-ken, Japan
- Kumamoto, Kumamoto, Japan
- Kyoto, Kyoto, Japan
- Tsu, Mie-ken, Japan
- Sendai, Miyagi, Japan
- Osaka, Osaka, Japan
- Hamamatsu, Shizuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anjo, Aichi-ken, Japan; Kasugai, Aichi-ken, Japan; Kōnan, Aichi-ken, Japan; Nagoya, Aichi-ken, Japan; Toyoake, Aichi-ken, Japan; Urayasu, Chiba, Japan and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.