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

NCT07585981 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • IgA Glomerulonephritis

Interventions

DRUG

NEFECON

Nefecon 16mg

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-10-01
Completion
2027-10-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585981 on ClinicalTrials.gov