Clinical Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome

NCT05914155 | Recruiting Phase 3

• 1 other identifier: CAMCR-020
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Glomerulonephritis, Membranous; Nephrotic Syndrome，Idiopathic

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving ICR I

  Achieving ICR I is defined as "Urine protein-creatinine ratio \< 1.0 g/gCr".

  up to 26 weeks

Secondary Outcomes (7)

• Percentage of patients who are CR, ICR I, ICR II, NR or PR

  up to 26 weeks

• Duration before achieving CR, ICR I, ICR II or PR

  up to 26 weeks

• Urine protein-creatinine ratio

  up to 26 weeks

• eGFR

  up to 26 weeks

• B-cells (CD19-positive and CD20-positive cells)

  up to 26 weeks

Study Arms (3)

Rituximab group in double-blind phase

ACTIVE COMPARATOR

Drug: Rituximab (genetical recombination)

Placebo group in double-blind phase

PLACEBO COMPARATOR

Drug: Placebo

Rituximab group in open-label phase

OTHER

Drug: Rituximab (genetical recombination)

Interventions

Rituximab (genetical recombination) DRUG

Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.

Rituximab group in double-blind phase

Placebo DRUG

Administer placebo IV infusion every two weeks for two doses in double-blind phase.

Placebo group in double-blind phase

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 informed consent
• 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, patients who are not willing to use contraceptive measures during the study period, or female patients not willing to use contraceptive measures until 12 months after the last dose of study drug (except for female patients who are unale to pregnant)
• Patients who are judged to be unsuitable by the investigator or a subinvestigator

Sponsors & Collaborators

• Shoichi Maruyama MD PhD: lead

Study Sites (18)

Anjo Kosei Hospital

Anjo, Aichi-ken, 4468602, Japan

RECRUITING

Kasugai Municipal Hospital

Kasugai, Aichi-ken, 486-8510, Japan

RECRUITING

Konan Kosei Hospital

Kōnan, Aichi-ken, 4838704, Japan

RECRUITING

Nagoya University Hospital

Nagoya, Aichi-ken, 4668560, Japan

RECRUITING

Fujita Health University hospital

Toyoake, Aichi-ken, 4701192, Japan

RECRUITING

Juntendo University Urayasu Hospital

Urayasu, Chiba, 2790021, Japan

RECRUITING

Kyushu University Hospital

Fukuoka, Fukuoka, 8128582, Japan

RECRUITING

Kurume University Hospial

Kurume, Fukuoka, 8300011, Japan

RECRUITING

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 0788510, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 9208641, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, 8608556, Japan

RECRUITING

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 6028566, Japan

RECRUITING

Kyoto University Hospital

Kyoto, Kyoto, 6068507, Japan

RECRUITING

Mie University Hospial

Tsu, Mie-ken, 5148507, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 9808574, Japan

RECRUITING

Tazuke Kofukai, Medical Research Institute, Kitano Hospital

Osaka, Osaka, 5308480, Japan

RECRUITING

Osaka University Hospital

Osaka, Osaka, 5650871, Japan

RECRUITING

Hamamatsu University Hosptial

Hamamatsu, Shizuoka, 4313129, Japan

RECRUITING

Related Publications (2)

• Shimizu S, Tanaka A, Matsuyama N, Kinoshita F, Furuhashi K, Maruyama S; PRIME Study Group. Randomised, double-blind study to evaluate the efficacy of rituximab in the treatment of idiopathic membranous nephropathy: A clinical trial protocol. PLoS One. 2025 Mar 18;20(3):e0320070. doi: 10.1371/journal.pone.0320070. eCollection 2025.

  PMID: 40100934 DERIVED

• Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

  PMID: 39513526 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Nephrosis, Lipoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Nephrosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shoichi Shoichi, PhD, MD

  Nagoya University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shoichi Maruyama, PhD, MD

CONTACT

+81527442192; marus@med.nagoya-u.ac.jp

Shinobu Shimizu, PhD

CONTACT

+81527442942; shimizu.shinobu.w3@f.mail.nagoya-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: June 24, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

JP (18)