Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NEFECON.
- Who it may be relevant to
- Registry conditions: IgA Glomerulonephritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug NEFECON
Nefecon 16mg
Primary outcome measures
- proteinuria [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility criteria
Inclusion criteria
- (1) Age ≥ 18 years (2) Primary IgA nephropathy confirmed by renal-biopsy pathology within the past 2 weeks (3) eGFR ≥ 20 mL/min/1.73 m² (4) 24-hour urinary protein 0.5-3.5 g/day (5) Patient has been fully informed, agrees to receive supportive care plus budesonide enteric-coated capsules, and has signed the informed-consent form
Exclusion criteria
- (1) Secondary IgAN attributable to, but not limited to, Henoch-Schönlein purpura, systemic lupus erythematosus, liver cirrhosis, rheumatoid arthritis, or ankylosing spondylitis (2) Previous renal transplantation or current dialysis (3) Co-existing glomerular disease on biopsy (e.g., C3 glomerulopathy, diabetic nephropathy) or nephrotic syndrome (4) Acute, chronic, or latent infection, including hepatitis, tuberculosis, HIV, or chronic urinary-tract infection (5) Type 1 or type 2 diabetes with poor control (HbA1c > 9 %) (6) History of unstable angina, NYHA class III/IV congestive heart failure, or clinically significant arrhythmia (7) Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg) (8) Malignancy diagnosed within the past 5 years (9) Known glaucoma, cataract, or history of cataract surgery (10) Gastro-intestinal disorders that may interfere with drug release or efficacy (peptic-ulcer disease, inflammatory bowel disease, chronic diarrhea) (11) Previous severe adverse reaction to corticosteroids, including psychotic symptoms (12) Concomitant use of potent cytochrome P450 3A4 (CYP3A4) inhibitors (13) Pregnancy, lactation, or unwillingness to use highly effective contraception during treatment and the 3-month follow-up (applies to women of child-bearing potential) (14) Patients whom the investigator deems unsuitable for budesonide enteric-coated-capsule therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT07585981 · 320.6750.2025-22-7