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

Conditions

• IgA Glomerulonephritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NEFECON — DRUG
  Nefecon 16mg

Study Details

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.

Key Dates

Start date

Oct 20, 2025

Status verified

Sep 2025

Primary completion

Oct 1, 2027

Completion

Oct 1, 2027

Study Design

Enrollment

30 participants (estimated)

Primary Outcome Measure

proteinuria [ Time Frame: From enrollment to the end of treatment at 12 months ]