What is budesonide studying for primary IgA nephropathy?

Researchers are studying the early use of budesonide capsules to see how they affect protein levels and kidney function in people with primary IgA nephropathy. The goal is to understand if starting this treatment early can impact the disease. This study is led by Sichuan Provincial People's Hospital.

Who may be eligible for this primary IgA nephropathy clinical trial?

Adults aged 18 to 75 with a recent diagnosis of primary IgA nephropathy confirmed by kidney biopsy may be eligible. Participants must have certain levels of kidney function and protein in urine and not have other serious health conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this primary IgA nephropathy clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 18Years - 75Years

All Genders

ID06676007

Study on Early Use of Budesonide Capsules for Treating Primary IgA Nephropathy in Adults Aged 18 to 75

Led by Sichuan Provincial People's Hospital · Updated on 2026-01-15

200

Participants Needed

Research Sites

25 weeks

Total Duration

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

Age: 18Years - 75Years

All Genders

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

Research Team

Guisen Li, Doctor

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Study on Early Use of Budesonide Capsules for Treating Primary IgA Nephropathy in Adults Aged 18 to 75

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria