Actively Recruiting
A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
Led by Sichuan Provincial People's Hospital · Updated on 2026-01-15
200
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
CONDITIONS
Official Title
A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Diagnosed with primary IgA nephropathy by kidney biopsy within 3 months
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73m2 or higher
- 24-hour urine protein of at least 1.0 g/day or urine protein-to-creatinine ratio of at least 0.8 g/g
- Signed informed consent
You will not qualify if you...
- Secondary IgA nephropathy caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, or ankylosing spondylitis
- History of kidney transplantation or dialysis
- Other glomerular diseases such as C3 glomerular disease or diabetic nephropathy, or nephrotic syndrome with proteinuria over 3.5 g/day, low serum albumin, with or without edema
- Acute, chronic, or potential infections like hepatitis, tuberculosis, HIV, or chronic urinary tract infections
- Poorly controlled type 1 or type 2 diabetes with HbA1c over 8%
- History of unstable angina, severe heart failure (grade III or IV), or significant arrhythmias
- Poor blood pressure control with systolic ≥140 mmHg or diastolic ≥90 mmHg
- Malignant tumors diagnosed within the past 5 years
- Known glaucoma, cataracts, or history of cataract surgery
- Gastrointestinal diseases affecting drug efficacy or release, like peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
- Severe past adverse reactions to steroids including psychiatric symptoms
- Systemic immunosuppressive or glucocorticoid treatment within 3 months before enrollment
- Use of strong cytochrome P450 3A4 inhibitors
- Current or recent (past 2 years) alcoholism or drug abuse
- Expected lifespan less than 5 years
- Women who are pregnant, breastfeeding, or unwilling to use effective contraception during treatment and 3-month follow-up
- Patients deemed unsuitable for treatment with Nefecon by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
Research Team
G
Guisen Li, Doctor
CONTACT
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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