Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome (PRIME)
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ClinicalTrials.gov Identifier: NCT05914155 |
Recruitment Status :
Recruiting
First Posted : June 22, 2023
Last Update Posted : July 21, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glomerulonephritis, Membranous Nephrotic Syndrome,Idiopathic | Drug: Rituximab (genetical recombination) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | June 24, 2023 |
Estimated Primary Completion Date : | December 31, 2026 |
Estimated Study Completion Date : | December 31, 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Rituximab group in double-blind phase |
Drug: Rituximab (genetical recombination)
Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase. |
Placebo Comparator: Placebo group in double-blind phase |
Drug: Placebo
Administer placebo IV infusion every two weeks for two doses in double-blind phase. |
Rituximab group in open-label phase |
Drug: Rituximab (genetical recombination)
Patients who remain to be ICR II (Incomplete Remission Type II) or NR (No Response) until Week 26 in the double-blind phase, if the patients wish to move to the open-label phase and the investigator or a subinvestigator considers the move necessary, the patient will move to the open-label phase and receive 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses after the readministration criteria are confirmed to be met. |
- Percentage of patients achieving ICR I [ Time Frame: up to 26 weeks ]Achieving ICR I is defined as "Urine protein-creatinine ratio < 1.0 g/gCr".
- Percentage of patients who are CR, ICR I, ICR II, NR or PR [ Time Frame: up to 26 weeks ]CR, ICR I, ICR II, NR or PR are defied as below; CR (Complete Remission): Urine protein-creatinine ratio < 0.3 g/gCr ICR I (Incomplete Remission Type I): 0.3 g/gCr ≤ Urine protein-creatinine ratio < 1.0 g/gCr ICR II (Incomplete Remission Type II): 1.0 g/gCr ≤ Urine protein-creatinine ratio < 3.5 g/gCr NR (No Response): 3.5 g/gCr ≤ Urine protein-creatinine ratio PR (Partial Remission): Decrease in urine protein-creatinine ratio from base line ≥50%, and urine protein-creatinine ratio 0.3 to 3.5 g/gCr
- Duration before achieving CR, ICR I, ICR II or PR [ Time Frame: up to 26 weeks ]Duration of achieving CR, ICR I, ICR II or PR is summarized.
- Urine protein-creatinine ratio [ Time Frame: up to 26 weeks ]The differences of urine protein-creatinine ratio between prior to treatment and at each timepoint are summarized.
- eGFR [ Time Frame: up to 26 weeks ]The differences of eGFR between prior to treatment and at each timepoint are summarized.
- B-cells (CD19-positive and CD20-positive cells) [ Time Frame: up to 26 weeks ]B cell counts (CD19 positive and CD20 positive cell counts) at each timepoint are summarized.
- Expression of HACA [ Time Frame: up to 26 weeks ]The number of patients expressing HACA, and the proportion of these patients at each timepoint are summarized.
- Serum rituximab (genetical recombination) concentration [ Time Frame: up to 26 weeks ]Serum rituximab (genetical recombination) level at each timepoint are summarized.
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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion 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 obtained from children)
Exclusion Criteria:
- 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)
- 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 Administration' in Japan) or patients who are participating in another study
- 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 the screening
- 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
- 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, or patients who are not willing to use contraceptive measures during the study period
- Patients who are judged to be unsuitable by the investigator or a subinvestigator
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05914155
Contact: Shoichi Maruyama, PhD, MD | +81527442192 | marus@med.nagoya-u.ac.jp | |
Contact: Shinobu Shimizu, PhD | +81527442942 | s-shimizu@med.nagoya-u.ac.jp |
Japan | |
Anjo Kosei Hospital | Recruiting |
Anjo, Aichi, Japan, 4468602 | |
Contact: Nobuhide Endo, PhD, MD +81566752111 ennob08@yahoo.co.jp | |
Kasugai Municipal Hospital | Recruiting |
Kasugai, Aichi, Japan, 486-8510 | |
Contact: Yosuke Saka, PhD, MD +81568570057 yosukesaka@hospital.kasugai.aichi.jp | |
Contact: Toshiaki Sawada +81568570057 chikenjimukyoku@hospital.kasugai.aichi.jp | |
Konan Kosei Hospital | Recruiting |
Kōnan, Aichi, Japan, 4838704 | |
Contact: Hiroshi Kojima, PhD, MD +81587513333 h-kojima@konan.jaaikosei.or.jp | |
Fujita Health University hospital | Recruiting |
Toyoake, Aichi, Japan, 4701192 | |
Contact: Naotake Tsuboi, PhD, MD +81562932111 nao-take@fujita-hu.ac.jp | |
Contact: Michiko Nakano +81562932139 nakanom@fujita-hu.ac.jp | |
Juntendo University Urayasu Hospital | Recruiting |
Urayasu, Chiba, Japan, 2790021 | |
Contact: Hitoshi Suzuki, PhD, MD +81473533111 shitoshi@juntendo.ac.jp | |
Kurume University Hospial | Recruiting |
Kurume, Fukuoka, Japan, 8300011 | |
Contact: Kei Fukami, PhD, MD +81942317002 fukami@kurume-u.ac.jp | |
Contact: Yusuke Kaida, PhD, MD +81942317002 kaida_yuusuke@kurume-u.ac.jp | |
Asahikawa Medical University Hospital | Recruiting |
Asahikawa, Hokkaido, Japan, 0788510 | |
Contact: Naoki Nakagawa, PhD, MD +81166682442 naka-nao@asahikawa-med.ac.jp | |
Kanazawa University Hospital | Recruiting |
Kanazawa, Ishikawa, Japan, 9208641 | |
Contact: Yasunori Iwata, PhD, MD +81762652499 iwatay@staff.kanazawa-u.ac.jp | |
Mie University Hospial | Recruiting |
Tsu, Mie, Japan, 5148507 | |
Contact: Kan Katayama, PhD, MD +81592321111 katayamk@med.mie-u.ac.jp | |
Contact: Tomoko Sugiura +81592315403 renal@med.mie-u.ac.jp | |
Hamamatsu University Hosptial | Recruiting |
Hamamatsu, Shizuoka, Japan, 4313129 | |
Contact: Hideo Yasuda, PhD, MD +81534352261 ysdh@hama-med.ac.jp | |
Kyushu University Hospital | Recruiting |
Fukuoka, Japan, 8128582 | |
Contact: Toshiaki Nakano, PhD, MD +81926425256 nakano.toshiaki.455@m.kyushu-u.ac.jp | |
Contact: Kenji Ueki, PhD, MD +81926425256 ueki.kenji.982@m.kyushu-u.ac.jp | |
University Hospital,Kyoto Prefectural University of Medicine | Recruiting |
Kyoto, Japan, 6028566 | |
Contact: Tetsuro Kusaba, PhD, MD +81752515111 kusaba@koto.kpu-m.ac.jp | |
Kyoto University Hospital | Recruiting |
Kyoto, Japan, 6068507 | |
Contact: Kaoru Sakai, PhD, MD +81757513111 | |
Osaka University Hospital | Not yet recruiting |
Osaka, Japan, 5650871 | |
Contact: Yoshitaka Isaka, PhD, MD +81668795111 |
Principal Investigator: | Shoichi Shoichi, PhD, MD | Nagoya University Hospital |
Responsible Party: | Shoichi Maruyama MD PhD, Professor, Nagoya University |
ClinicalTrials.gov Identifier: | NCT05914155 |
Other Study ID Numbers: |
CAMCR-020 |
First Posted: | June 22, 2023 Key Record Dates |
Last Update Posted: | July 21, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | If the principal investigator, clinical trial office, main stakeholder conclude that secondary use of individual data obtained in this clinical trial is beneficial for additional analysis, the secondary use of data excluding personal information will be acceptable after publication of results. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nephrotic Syndrome Nephrosis Glomerulonephritis Glomerulonephritis, Membranous Syndrome Disease Pathologic Processes Kidney Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Male Urogenital Diseases Nephritis Autoimmune Diseases Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |