Actively Recruiting
Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.
Led by Chinese PLA General Hospital · Updated on 2026-05-14
30
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early Application of Budesonide Enteric-coated Capsules in the Treatment of Primary IgA Nephropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Primary IgA nephropathy confirmed by kidney biopsy within the past 2 weeks
- Estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73 m² or higher
- Proteinuria between 0.5 and 3.5 grams per day
- Patient agrees to receive supportive care plus budesonide enteric-coated capsules and has signed informed consent
You will not qualify if you...
- Secondary IgA nephropathy caused by conditions such as Henoch-Schönlein purpura, lupus, liver cirrhosis, rheumatoid arthritis, or ankylosing spondylitis
- Previous kidney transplant or current dialysis treatment
- Other glomerular diseases or nephrotic syndrome seen on biopsy
- Active, chronic, or latent infections including hepatitis, tuberculosis, HIV, or chronic urinary tract infection
- Poorly controlled type 1 or type 2 diabetes (HbA1c over 9%)
- History of unstable angina, severe heart failure (NYHA III/IV), or significant heart rhythm problems
- Uncontrolled high blood pressure (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg)
- Cancer diagnosed within the last 5 years
- Known glaucoma, cataracts, or previous cataract surgery
- Gastrointestinal disorders that could affect drug release or effectiveness
- Severe past reactions to corticosteroids including psychotic symptoms
- Use of strong cytochrome P450 3A4 inhibitors
- Pregnancy, breastfeeding, or unwillingness to use highly effective contraception during treatment and 3-month follow-up
- Investigator judges patient unsuitable for budesonide enteric-coated capsule therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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