The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy (NCT06614985) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
China172 participantsStarted 2024-10-20
Plain-language summary
This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.
✓. Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.
✓. 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.
✓. 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.
✓. 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
✕. Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);
✕. 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;
What they're measuring
1
Complete remission rate at the end of follow-up (21 months post-treatment)
Timeframe: 21 months
2
Partial remission rate at the end of follow-up (21 months post-treatment)