Actively Recruiting
Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
Led by Shoichi Maruyama MD PhD · Updated on 2025-02-11
88
Participants Needed
18
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
CONDITIONS
Official Title
Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic membranous nephropathy confirmed by kidney biopsy before consent
- Diagnosis of nephrotic syndrome before consent with no steroids or immunosuppressants used within 12 weeks prior
- Urine protein-creatinine ratio of 3.5 g/gCr or higher at screening
- Serum albumin of 3.0 g/dL or lower at screening
- Age 15 years or older at informed consent
- Provided voluntary written consent after receiving study information (with legal representative consent and assent for underage patients)
You will not qualify if you...
- Primary nephrotic syndrome other than membranous nephropathy or secondary nephrotic syndrome due to autoimmune, metabolic, infection, allergic/hypersensitive, tumor, or drug-induced causes
- Reduced kidney function with eGFR below 30 mL/min/1.73 m2 at screening
- Previous use of anti-CD20 antibody including rituximab for idiopathic membranous nephropathy
- Participation in another clinical study within 12 weeks before consent, except studies within indications or dosage ranges in Japan, or current participation in another study
- History of kidney transplant
- Poorly controlled diabetes with HbA1c of 8.0% or higher
- Active infection requiring systemic antimicrobial, antifungal, or antiviral treatment at consent
- Positive tests for hepatitis B or C markers, HIV, or HTLV-1 antibodies; exceptions apply if HBV-DNA test is negative
- Leukopenia (less than 2,000/mm3), neutropenia (less than 1,000/mm3), or lymphopenia (less than 500/mm3) at screening
- History of serious allergic or anaphylactic reaction to study drug ingredients or murine protein products
- Life-threatening nephrotic syndrome as judged by investigators
- Serious comorbid conditions such as liver, kidney (other than this condition), heart, lung, blood, or brain diseases
- Pregnant, lactating, potentially pregnant females, or unwillingness to use contraception during and up to 12 months after study drug dosing (except females unable to become pregnant)
- Judged unsuitable for participation by investigators
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Anjo Kosei Hospital
Anjo, Aichi-ken, Japan, 4468602
Actively Recruiting
2
Kasugai Municipal Hospital
Kasugai, Aichi-ken, Japan, 486-8510
Actively Recruiting
3
Konan Kosei Hospital
Kōnan, Aichi-ken, Japan, 4838704
Actively Recruiting
4
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 4668560
Actively Recruiting
5
Fujita Health University hospital
Toyoake, Aichi-ken, Japan, 4701192
Actively Recruiting
6
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan, 2790021
Actively Recruiting
7
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 8128582
Actively Recruiting
8
Kurume University Hospial
Kurume, Fukuoka, Japan, 8300011
Actively Recruiting
9
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, 0788510
Actively Recruiting
10
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 9208641
Actively Recruiting
11
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan, 8608556
Actively Recruiting
12
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan, 6028566
Actively Recruiting
13
Kyoto University Hospital
Kyoto, Kyoto, Japan, 6068507
Actively Recruiting
14
Mie University Hospial
Tsu, Mie-ken, Japan, 5148507
Actively Recruiting
15
Tohoku University Hospital
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
16
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Osaka, Osaka, Japan, 5308480
Actively Recruiting
17
Osaka University Hospital
Osaka, Osaka, Japan, 5650871
Actively Recruiting
18
Hamamatsu University Hosptial
Hamamatsu, Shizuoka, Japan, 4313129
Actively Recruiting
Research Team
S
Shoichi Maruyama, PhD, MD
CONTACT
S
Shinobu Shimizu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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