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

Launched by SHOICHI MARUYAMA MD PHD · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called rituximab for patients with idiopathic membranous nephropathy who also have nephrotic syndrome. Nephrotic syndrome is a condition where the kidneys leak too much protein into the urine, leading to swelling and other complications. The goal of the study is to confirm whether rituximab is effective and safe for treating this condition. The trial is currently recruiting participants aged 15 and older who have been diagnosed with idiopathic membranous nephropathy through a kidney biopsy and have specific symptoms, like high levels of protein in their urine and low levels of albumin in their blood.

If you or someone you know is considering participating in this trial, it's important to be aware of the eligibility criteria. Participants should not have taken steroids or certain other medications in the 12 weeks before joining, and they should not have other types of kidney disease or serious infections. Throughout the trial, participants will receive infusions of rituximab and will be closely monitored for any side effects or changes in their condition. This study could help improve treatment options for patients with this kidney disease.

Gender

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Eligibility 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 informed consent
• • 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, 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)
• • 14. Patients who are judged to be unsuitable by the investigator or a subinvestigator