Clinical Trial

Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.

Recruiting
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Summary
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.
Trial Details
NCT Number NCT07585981
Lead Sponsor Chinese PLA General Hospital
Conditions IgA Glomerulonephritis
Enrollment 30 participants
Start Date 2025-10-20
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-14