The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy

Launched by RENMIN HOSPITAL OF WUHAN UNIVERSITY · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Telitacicept for adults with primary membranous nephropathy, a kidney disease that can cause serious problems like swelling and high protein levels in urine. The study aims to see how safe and effective Telitacicept is in helping patients manage their condition. It is designed for adults aged 18 and older who have been diagnosed with this specific type of kidney disease and have certain symptoms, such as high levels of protein in their urine and low albumin levels in their blood.

If you or someone you know is considering participating, it’s important to know that participants will need to meet specific health criteria and will have to sign a consent form to join. They will also need to use effective contraception throughout the study. Participants can expect to receive the treatment and be monitored closely for any effects, both good and bad. This trial is currently not recruiting participants, so it's a good time to learn more and discuss with a healthcare provider if this might be an option in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.
• • 2. Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.
• • 3. Patients who meet the diagnostic criteria for nephrotic syndrome, which includes quantitative urine protein levels greater than 3.5 g/24 h and serum albumin levels less than 30 g/L, are eligible for inclusion in the study.
• • 4. Patients who meet the high-risk criteria for progression of membranous nephropathy based on the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines are eligible for inclusion in the study. High-risk criteria include eGFR less than 60 mL/min/1.73 m2 and/or urine protein excretion greater than 8 g/day for at least 6 months, or normal eGFR with urine protein excretion greater than 3.5 g/day and urine protein reduction less than 50% after 6 months of ACEI/ARB treatment, with any of the following criteria: serum albumin less than 25 g/L, anti-PLA2R antibody greater than 50 RU/mL, urine α1-microglobulin greater than 40 μg/min, urine IgG1 greater than 1 μg/min, urine β2-microglobulin greater than 250 mg/day, and SI greater than 0.2.
• • 5. Participants are required to consent to use effective contraception methods with their partners throughout the entire duration of the study. Participants must have a thorough understanding of the nature, significance, potential benefits, inconveniences, and potential risks of the study and voluntarily sign an informed consent form.
• Exclusion Criteria:
• • 1. Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);
• • 2. Patients with HIV infection, viral hepatitis, active liver disease (with ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;
• • 3. Patients with a rapid decline in eGFR (\>15 mL/min) during the screening period are excluded;
• • 4. Patients who have undergone kidney transplantation or other organ transplantation;
• • 5. Patients with a known allergy or hypersensitivity to the active ingredient of the investigational drug or any of the listed excipients;
• • 6. Patients with acute or critical cardiovascular or cerebrovascular diseases;
• • 7. Patients with immunodeficiency, hypoalbuminemia (IgG \< 400 mg/dl), or IgA deficiency (IgA \< 10 mg/dL);
• • 8. Pregnant or lactating women;
• • 9. Patients diagnosed with malignant tumors within the past 5 years;
• • 10. Laboratory findings of severe abnormalities (Hb \< 80 g/L, PLT \< 50,000/mm3, neutrophil count \< 1,000/mm3, etc.);
• • 11. Patients who have used steroids or immunosuppressive agents (including but not limited to corticosteroids, adrenocorticotropic hormones, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, biologic agents such as rituximab, etc.), cyclophosphamide, bortezomib, dexamethasone, Chinese medicines or preparations containing Tripterygium wilfordii, intravenous immunoglobulin, plasma exchange, leukapheresis, live vaccines, or other investigational drugs, etc., within 3 months prior to screening;
• • 12. Patients with other diseases or conditions that, in the opinion of the investigator, would render the patient unsuitable for participation in this study;