Randomised, double-blind study to evaluate the efficacy of rituximab in the treatment of idiopathic membranous nephropathy: A clinical trial protocol.
Shinobu Shimizu, Akihito Tanaka, Nao Matsuyama...
https://pubmed.ncbi.nlm.nih.gov/40100934Actively Recruiting
Phase 3
Age: 15Years +
All Genders
ID05914155
The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
Led by Shoichi Maruyama MD PhD · Updated on 2025-02-11
88
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to confirm the effectiveness and safety of rituximab (genetical recombination) given through an intravenous infusion to people with idiopathic membranous nephropathy who also have nephrotic syndrome. The study is a phase 3 clinical trial led by Shoichi Maruyama MD PhD, involving a randomized, double-blind, placebo-controlled design to compare rituximab against a placebo. Participants will be randomly assigned to receive either 1,000 mg of rituximab or a placebo by intravenous infusion every two weeks for two doses during the double-blind phase. Those who do not respond adequately by Week 26 may choose to enter an open-label phase and receive rituximab again under certain conditions. The study carefully monitors patients throughout these phases to evaluate treatment effects. During the study, participants will undergo assessments up to 26 weeks, including measurements of urine protein-creatinine ratio, kidney function (eGFR), and B-cell counts. Researchers will also track the presence of antibodies and serum drug levels to evaluate treatment response. The main measure is the percentage of patients reaching a defined remission level within 26 weeks. Safety and treatment effects will be closely observed throughout the trial.
CONDITIONS
Brief Title
Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome
Who Can Participate
Age: 15Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who have undergone kidney biopsy and are diagnosed with idiopathic membranous nephropathy before giving consent
- Patients diagnosed with nephrotic syndrome and have not used steroids or immunosuppressants within 12 weeks before consent
- Patients with a urine protein-creatinine ratio of 3.5 g/gCr or higher at screening
- Patients with serum albumin of 3.0 g/dL or lower at screening
- Patients aged 15 years or older at the time of consent
- Patients who give voluntary written consent (legally acceptable representatives must consent for underage patients, with informed assent from children)
You will not qualify if you...
- Patients with other primary or secondary nephrotic syndromes (such as IgA nephropathy, minimal change disease, autoimmune disease, infections, tumors, or drug-induced disease)
- Patients with renal function below eGFR 30 mL/min/1.73 m2 at screening
- Patients who have previously used anti-CD20 antibodies including rituximab for this condition
- Patients participating in another clinical study within 12 weeks before consent, except for related studies allowed in Japan, or currently participating in another study
- Patients with a history of kidney transplant
- Patients with poorly controlled diabetes (HbA1c 8.0% or higher)
- Patients with active infections requiring systemic treatment at consent
- Patients testing positive for hepatitis B, hepatitis C, HIV, or HTLV-1 antibodies unless HBV-DNA is negative when applicable
- Patients with low white blood cell counts at screening
- Patients with serious allergic reactions to study drug ingredients or murine proteins
- Patients judged to have life-threatening nephrotic syndrome
- Patients with serious other health conditions (such as liver, heart, lung, blood, or brain diseases)
- Female patients who are pregnant, breastfeeding, potentially pregnant, or unwilling to use contraception during and for 12 months after the study unless unable to become pregnant
- Patients considered unsuitable by the investigator or subinvestigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 26 weeks
Participants receive either rituximab or placebo via intravenous infusion every two weeks for two doses in the double-blind phase.
2 infusion visits every two weeks
Treatment
Duration - Variable following Week 26
Participants who do not achieve remission by Week 26 may move to an open-label phase and receive two additional rituximab infusions every two weeks after meeting readministration criteria.
2 infusion visits every two weeks
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
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Research Team
S
Shoichi Maruyama, PhD, MD
S
Shinobu Shimizu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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Published Research Related To This Trial
Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children.
Nicholas G Larkins, Deirdre Hahn, Isaac D Liu...
https://pubmed.ncbi.nlm.nih.gov/39513526