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Clinical Trials in China / NCT06614985
Starting soon Phase 2

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

NCT06614985 · tracked via the Priya Life Science China tracker
Sponsor
Renmin Hospital of Wuhan University
Phase
Phase 2
Started
2024-10-20
Last updated
2024-09-26

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

TelitaciceptPrednisoneCyclophosphamide

Telitacicept: Subcutaneous injection of 160 mg is administered once a week.

Prednisone: Induction therapy period (3 months):Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation.

Cyclophosphamide: An intravenous injection of 0.4 g is administered twice a month.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Renmin Hospital of Wuhan university Wuhan Hubei China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06614985 on ClinicalTrials.gov ↗ ← All trials in China