Actively Recruiting
A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of starting budesonide enteric coated capsules early to treat primary IgA nephropathy, a kidney condition. This prospective, open-label study involves multiple centers and aims to observe changes in proteinuria levels and monitor for any treatment-related abnormal lab values or adverse events over about 12 months. Participants will receive targeted-release budesonide capsules as part of the study. The research includes collecting and testing Gd-IgA1 levels in enrolled subjects. The study is observational, focusing on early initiation of therapy for patients diagnosed within 3 months, with kidney function and protein levels meeting specific criteria. During the study, participants will be regularly assessed for kidney function, protein in urine, microscopic hematuria, and metabolic changes through laboratory tests and urine analysis. Researchers will also track serious kidney outcomes and side effects related to treatment. The total participation period covers about 12 months, including follow-up to evaluate the long-term effects of the therapy.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Diagnosed with primary IgA nephropathy by kidney biopsy within the last 3 months
- Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2
- 24-hour urine protein of 1.0 g or more, or urine protein-to-creatinine ratio of 0.8 g/g or higher
- Signed informed consent
You will not qualify if you...
- Secondary IgA nephropathy caused by conditions like allergic purpura, lupus, cirrhosis, rheumatoid arthritis, or ankylosing spondylitis
- History of kidney transplant or dialysis
- Other glomerular diseases such as C3 glomerular disease, diabetic nephropathy, or nephrotic syndrome
- Acute, chronic, or potential infections including hepatitis, tuberculosis, HIV, or chronic urinary tract infections
- Poorly controlled type 1 or type 2 diabetes (HbA1c > 8%)
- History of unstable angina, severe heart failure, or significant arrhythmias
- Poor blood pressure control (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg)
- Cancer diagnosis within the past 5 years
- Known glaucoma, cataracts, or history of cataract surgery
- Gastrointestinal diseases interfering with drug effectiveness, such as peptic ulcer, inflammatory bowel disease, or chronic diarrhea
- Severe adverse reactions to steroids including psychiatric symptoms
- Systemic immunosuppressive or glucocorticoid treatments within 3 months before enrollment
- Use of strong cytochrome P450 3A4 inhibitors
- Alcoholism or drug abuse in the past 2 years
- Expected lifespan less than 5 years
- Pregnant, breastfeeding, or unwilling to use effective contraception during study and 3-month follow-up
- Deemed unsuitable for treatment with Nefecon by researchers
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 - About 12 months
Participants are observed to evaluate changes in kidney function and proteinuria levels over time.
Regular assessments during the 12-month period
Trial Site Locations
Total: 1 location
1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
Research Team
G
Guisen Li, Doctor
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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