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The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.
The main questions it aims to answer are:
Participants will be subcutaneously injected with 240mg of Telitacicept once per week.
Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telitacicept treated group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Drug | Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical response | a. Proteinuria: protein-to-creatinine ratio <0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase. | 3-year |
| The absolute value of eGFR | The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline | 3-year |
| Changes in 24-hour urinary protein | Changes in 24-hour urinary protein at week 104 compared with baseline. | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR decrease | The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline. | 3-year |
| Need for dialysis | progression to end-stage renal disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
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| 3-year |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |