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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
Sponsor:
Information provided by (Responsible Party):
Shoichi Maruyama MD PhD, Nagoya University

Study Description
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Brief Summary:
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, Membranous Nephrotic Syndrome，Idiopathic Drug: Rituximab (genetical recombination) Drug: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Rituximab

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. eGFR [ Time Frame: up to 26 weeks ]
    The differences of eGFR between prior to treatment and at each timepoint are summarized.

  5. 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.

  6. 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.

  7. Serum rituximab (genetical recombination) concentration [ Time Frame: up to 26 weeks ]
    Serum rituximab (genetical recombination) level at each timepoint are summarized.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent
  2. 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
  3. Patients with urine protein-creatinine ratio ≥ 3.5 g/gCr at the screening
  4. Patients with hypoalbuminemia (serum albumin ≤ 3.0 g/dL) at the screening
  5. Patients aged 15 years or older at informed consent
  6. 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:

  1. 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)
  2. Patients with the renal function lowered (eGFR <30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening
  3. Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent for idiopathic membranous nephropathy
  4. 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
  5. Patients with history of renal transplant
  6. Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
  7. 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
  8. 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
  9. 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
  10. Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
  11. Patients who are judged to be life-threatening nephrotic syndrome by the investigator or a subinvestigator
  12. Patients with serious comorbidity (e.g., hepatic, renal (excluding idiopathic membranous nephropathy with nephrotic syndrome), cardiac, lung, hematologic, or brain disease)
  13. Female patients who are pregnant, lactating, or potentially pregnant, or patients who are not willing to use contraceptive measures during the study period
  14. Patients who are judged to be unsuitable by the investigator or a subinvestigator
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Shoichi Maruyama, PhD, MD +81527442192 marus@med.nagoya-u.ac.jp
Contact: Shinobu Shimizu, PhD +81527442942 s-shimizu@med.nagoya-u.ac.jp

Locations
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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      
Sponsors and Collaborators
Shoichi Maruyama MD PhD
Investigators
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Principal Investigator: Shoichi Shoichi, PhD, MD Nagoya University Hospital
More Information
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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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