Studies early budesonide treatment in people with primary IgA nephropathy
Observes early budesonide capsule treatment in adults with primary IgA nephropathy, a kidney disease.
Plain-language title generated from the registry record
Registry title: A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
Key facts
- Where
- Chengdu, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06676007, who can take part
Where in China
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Provincial People's Hospital
- Trial code
- NCT06676007
- Record updated
- 15 January 2026
- Original description
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.Read full original descriptionShow less
A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
Inclusion: Target patients aged 18-75, including those aged 18 and 75; Primary IgA nephropathy diagnosed by renal biopsy within 3 months; eGFR≥30ml/min/1.73m2; 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g; Sign informed consent.
Exclusion: Patients who have received kidney transplantation or dialysis; Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment; Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment; Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4); Current or previous (within the past 2 years) alcoholism or drug abuse; Researchers believe that patients who are not suitable for treatment with Nefecon; Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis; Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections; Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias; Patients diagnosed with malignant tumors within the past 5 years; Patients with known glaucoma, known cataracts, and/or a history of cataract surgery; Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea; Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms; Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria>3.5 g/d, serum albumin<3.0 g/dl, with or without edema); Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c>8%); Expected lifespan<5 years; Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg); During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential).