Early budesonide capsules plus standard care for IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study enrolls adults with biopsy-confirmed primary IgA nephropathy and modest-to-severe proteinuria. Participants receive early real-world combination therapy with a renin-angiotensin system blocker (irbesartan), an SGLT2 inhibitor (dapagliflozin), and budesonide enteric-coated capsules for 9 months, followed by a budesonide taper while continuing irbesartan and dapagliflozin for 3 more months. The primary endpoint is the change in proteinuria from baseline to month 12; secondary endpoints include changes in eGFR and microscopic hematuria. The study aims to observe safety and potential effectiveness of this early, combined approach in routine clinical practice. Enrollment targets adults aged 18 and older with specific renal function and proteinuria criteria, excluding those with secondary IgA nephropathy or significant comorbid conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.