The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome (PRIME Study)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:
• 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 obtained from children)
Locations
Other Locations
Japan
Anjo Kosei Hospital
RECRUITING
Anjo
Asahikawa Medical University Hospital
RECRUITING
Asahikawa
Kyushu University Hospital
RECRUITING
Fukuoka
Hamamatsu University Hosptial
RECRUITING
Hamamatsu
Kanazawa University Hospital
RECRUITING
Kanazawa
Kasugai Municipal Hospital
RECRUITING
Kasugai
Konan Kosei Hospital
RECRUITING
Kōnan
Kumamoto University Hospital
RECRUITING
Kumamoto
Kurume University Hospial
RECRUITING
Kurume
Kyoto University Hospital
RECRUITING
Kyoto
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Nagoya University Hospital
RECRUITING
Nagoya
Osaka University Hospital
RECRUITING
Osaka
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
RECRUITING
Osaka
Tohoku University Hospital
RECRUITING
Sendai
Fujita Health University hospital
RECRUITING
Toyoake
Mie University Hospial
RECRUITING
Tsu
Juntendo University Urayasu Hospital
RECRUITING
Urayasu
Contact Information
Primary
Shoichi Maruyama, PhD, MD
marus@med.nagoya-u.ac.jp
+81527442192
Backup
Shinobu Shimizu, PhD
shimizu.shinobu.w3@f.mail.nagoya-u.ac.jp
+81527442942
Time Frame
Start Date:2023-06-24
Estimated Completion Date:2027-12-31
Participants
Target number of participants:88
Treatments
Active_comparator: Rituximab group in double-blind phase
Placebo_comparator: Placebo group in double-blind phase