primary membranous nephropathy
Conditions
Interventions
Test Group:Tacrolimus+Telitacicept
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years at enrollment; 2. Patients diagnosed with primary membranous nephropathy by renal biopsy; 3. Positive for anti-PLA2R antibody; 4. 24-hour urinary protein>3.5g/24h and serum albumin=60mL/min/1.73m^2 calculated by the CKD-EPI formula; 6. Subjects agree to use effective contraceptive measures with their partners throughout the study period; 7. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary membranous nephropathy(caused by autoimmune diseases, infectious diseases, drugs, tumors, etc.);2. Patients with known allergy or hypersensitivity to the active ingredients of the study drugs or any listed excipients;3. Patients who had myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic events within 24 weeks prior to the start of the screening period;4. Patients who underwent major surgery(including joint surgery) within 24 weeks prior to screening, or plan to undergo surgery within 24 weeks after enrollment;5. Patients with HIV infection, syphilis, active tuberculosis, or untreated latent tuberculosis;6. Patients with uncontrolled active infection at screening(excluding uncomplicated urinary tract infection and bacterial pharyngitis);7. Patients with active HBV or HCV infection;8. Patients with active liver disease(defined as: ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal) or severe liver disease(e.g., cirrhosis) at screening;9. Patients with a rapid decline in eGFR(>15mL/min/1.73m^2) during the screening period;10. Patients with severe abnormalities in laboratory test results (e.g., hemoglobin=5 years, skin basal cell or squamous cell carcinoma that has been radically resected, or carcinoma in situ at any site;13. Patients who have used B-cell targeted drugs(e.g., rituximab, ocrelizumab, belimumab, alemtuzumab, bortezomib, CD38 monoclonal antibody) or other biological agents within the past 12 weeks;14. Patients who have used systemic glucocorticoids or immunosuppressants within the past 12 weeks, including but not limited to: cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.;15. Patients who have used any investigational drug within 28 days prior to screening, or within 5 half-lives of the investigational drug(whichever is longer);16. Patients who have received live vaccines within 24 weeks prior to screening;17. Patients with a history of alcohol or drug abuse within the past 24 weeks;18. Patients who are pregnant, lactating, or have plans for childbearing within 6 months after the completion of the trial;19. Patients deemed by the investigator to have other reasons unsuitable for participating in this clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission rate (including complete remission + partial remission);Immunological remission rate (the proportion of patients with seronegative conversion of PLA2R antibody);Change in anti-PLA2R antibody level from baseline;Ratio of 24-hour urine protein to baseline;Change in eGFR from baseline;Change in serum albumin from baseline;Incidence rate and severity grade of adverse events or serious adverse events during treatment; | — |
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate ; | — |
Countries
China
Contacts
Public ContactShiren Sun
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed