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This multicenter, open-label, prospective single-arm study will enroll adults (≥18 y) with primary IgA nephropathy confirmed by renal biopsy within 2 weeks, eGFR ≥20 ml/min/1.73 m² and 0.5-3.5 g/d proteinuria, to receive early (real-world) combination therapy with RASI (titrated irbesartan), SGLT2i (dapagliflozin 10 mg qd) and budesonide enteric-coated capsules (16 mg qd) for 9 months, followed by budesonide taper-off and continuation of RASI+SGLT2i for 3 more months (12 months total), with primary endpoint being change in proteinuria from baseline to month 12 and secondary endpoints changes in eGFR and microscopic hematuria.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEFECON | Drug | Nefecon 16mg |
| Measure | Description | Time Frame |
|---|---|---|
| proteinuria | Change in proteinuria from baseline to Month 12 | From enrollment to the end of treatment at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Age ≥ 18 years,primary IgA nephropathy confirmed by renal-biopsy pathology within the past 2 weeks,eGFR ≥ 20 mL/min/1.73 m²,24-hour urinary protein 0.5-3.5 g/day,patient has been fully informed, agrees to receive supportive care plus budesonide enteric-coated capsules, and has signed the informed-consent form
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | 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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| 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 |