IgA nephropathy
Conditions
Interventions
Telitacicept treatment group:Subcutaneous injection of Telitacicept 240mg, the injection site can be the thigh, abdomen or upper arm once a week, for a course of 24 weeks, while monitoring blood pres
Hormones and Telitacicept treatment group:In addition to hormone therapy, Telitacicept was administered subcutaneously at a dose of 160 mg, with injection sites the thigh, abdomen, or upper arm, once
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this study and signed the informed consent form; 2. Diagnosed with IgA nephropathy by renal pathological biopsy, Lee grading III-V; 3. After 3 months of treatment with the maximum tolerated dose of RAS inhibitor, the 24-hour urine protein quantification is >=750mg or after 6 months of treatment with renin-angiotensin system (RAS) blocker combined with glucocorticoid/immunosuppressive agent, the 24-hour urine protein quantification is >=750mg. 4. Age 18-70 years, gender unrestricted; 5. Estimated glomerular filtration rate (eGFR) >=45 mL/(min·1.73 m²) (using the CKD-EPI formula).
Exclusion criteria
Exclusion criteria: 1. Exclude secondary IgA nephropathy, IgA nephropathy crescentic glomerulonephritis (pathological diagnosis crescents >50%); 2. Known allergy to the study drug; 3. Concurrent active infectious diseases, such as hepatitis B or C virus infection, AIDS ,acute pneumonia, etc.; 4. Pregnant women or those planning to become pregnant, lactating women; 5. History of malignant tumors; 6. Use biological agents in the past 6 months, such as CD20 monoclonal antibodies, belimumab, etc.; 7. Other reasons deemed unsuitable participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;Serum albumin;urine albumin/creatinine ratio;24-hour urine protein quantification ; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;White blood cell;Blood cholesterol;TBNK cell count; humoral immunity;glycated IgA1; | — |
Countries
China
Contacts
Public ContactXie Rong
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed