RecruitingNCT07585981

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


Sponsor

Chinese PLA General Hospital

Enrollment

30 participants

Start Date

Oct 20, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NEFECON for people with iga glomerulonephritis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNEFECON

Nefecon 16mg


Locations(1)

Chinese PLA General Hospital

Beijing, China

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NCT07585981


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