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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating early combination therapy for adults with primary IgA nephropathy, a kidney condition confirmed by biopsy within two weeks. Participants must have an estimated glomerular filtration rate (eGFR) of at least 20 ml/min/1.73 m² and proteinuria between 0.5 and 3.5 grams per day. The study aims to assess changes in proteinuria over 12 months, with additional focus on kidney function and microscopic blood in urine. Participants will receive a combination of treatments including renin-angiotensin system inhibitors (specifically titrated irbesartan), sodium-glucose cotransporter 2 inhibitors (dapagliflozin 10 mg once daily), and budesonide enteric-coated capsules (16 mg once daily) for nine months. After this, the budesonide dose will be gradually reduced while continuing the other two medications for an additional three months, totaling one year of treatment. Throughout the study, participants will undergo regular monitoring to evaluate protein levels in urine, kidney function via eGFR, and microscopic hematuria. Researchers will track these outcomes from enrollment to the end of treatment at 12 months. The study is conducted at multiple centers and sponsored by the Chinese PLA General Hospital, involving adults aged 18 years and older who meet the specific kidney health criteria.
CONDITIONS
Brief 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 at least 20 ml/min/1.73 m²
- 24-hour urinary protein between 0.5 and 3.5 grams per day
- Fully informed and agrees to receive supportive care plus budesonide enteric-coated capsules with signed consent form
You will not qualify if you...
- Secondary IgA nephropathy due to conditions such as Henoch-Schönlein purpura, systemic lupus erythematosus, liver cirrhosis, rheumatoid arthritis, or ankylosing spondylitis
- Previous kidney transplant or current dialysis
- Other glomerular diseases or nephrotic syndrome
- Acute, 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 class III/IV), or serious arrhythmia
- Uncontrolled high blood pressure (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg)
- Cancer diagnosed within the past 5 years
- Known glaucoma, cataracts, or history of cataract surgery
- Gastrointestinal disorders affecting drug release or effectiveness
- Severe past allergic reaction to corticosteroids
- Use of strong CYP3A4 inhibitors
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during treatment and 3-month follow-up
- Investigator judgment deeming patient unsuitable for budesonide therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive supportive care plus budesonide enteric-coated capsules (Nefecon 16mg) for primary IgA nephropathy.
Regular visits during the 12 months of treatment
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here