IgAnephropathy
Conditions
Interventions
Telitacicept group:Based on the basic treatment, the patients were treated with Telitacicept L. Administration of Telitacicept subcutaneously at a dose of 240 mg once a week
Control Group:Basic therapeutic drugs. In this study, ACEI/ARB drugs were used as basic drugs.
Sponsors
Ningxia Medical University General
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Older than 18; 2. The 24-hour urinary protein was =0.5 g in patients with IgA nephropathy. 3. Estimated glomerular filtration rate (EGFR) calculated using the CKD-EPI formula was satisfied: EGFR =30 mL/min/1.73 m2; 4. Had received at least 12 weeks of tolerable blood pressure ACEI/ARB prior to the first dose, and 4 weeks before the first use of drugs in a stable maximum tolerated dose/specification of the maximum allowable dose of ACEI/ARB drug treatment period. 5. Follow-up regularly 6. Volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary IgA nephropathy, including Henoch–Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, etc. 2. Patients with glomerulosclerosis (=75%) , crescentic glomerulonephritis (crescentic glomerulonephritis) , minimal change nephropathy (minimal change nephropathy) with IGA deposition and other types of glomerular diseases; 3. Renal transplant recipients; liver cirrhosis; patients with type 1 or type 2 diabetes mellitus; 4. Patients diagnosed with any of the following cardio-cerebrovascular events within 12 weeks before enrollment: myocardial infarction, unstable angina, ventricular arrhythmias, New York Heart Association Class II or higher heart failure, stroke, etc. 5. Immunosuppressants including but not limited to cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii, etc. were used in the 12 weeks before randomization. 6. CD20 antibody was used in the 12 weeks before randomization. 7. During the first 4 weeks, patients with active infection were admitted to hospital or received intravenous anti-infection therapy. 8. Active and untreated latent tuberculosis. 9. Active or latent hepatitis B; 10. Hepatitis C patients;11. Human immunodeficiency virus (HIV) infection; 12. In addition to treated skin basal-cell carcinoma, effectively resected skin squamous-cell carcinoma, colon polyps, or cervical cancer in situ, patients diagnosed with malignancy within the past 5 years are eligible for treatment. 13. Pregnant women, lactating women and men or women who plan to have children during the trial period. 14. Patients given any clinical trial drug 4 weeks before randomization or within 5 times the half-life of the trial drug (longer) ; 15. Live vaccination within 4 weeks before randomization. 16. Patients with positive test results within 4 weeks of randomization suggesting COVID-19 infection or with a history of severe COVID-19 requiring hospitalization within 52 weeks before screening; 17. White blood cell count was 3 × 109/L; 18. The absolute value of neutrophil was 1.5 × 109/L; 19. Hemoglobin & LT; 85 g/L; 20. Platelet count: 80 × 10 ~ 9/L; 21. Total Bilirubin & GT. 1.5 upper limit of normal value; 22.5. Alt & GT. 3 upper limit of normal or AST & GT. 3 upper limit of normal. Alkaline phosphatase > > > 24. Creatine kinase > GT. 5 upper limit of normal value 25.5% . Other subjects the researchers considered unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum creatinine; | — |
Countries
China
Contacts
Public ContactNa Tian
Ningxia Medical University General
Outcome results
None listed