IgA nephropathy
Conditions
Interventions
Observation group:None
Sponsors
Second People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria: Patients must meet all of the following inclusion criteria at screening to be eligible for participation in this study: (1) Primary IgA nephropathy confirmed by kidney biopsy; (2) Age >=18 years; (3) 24-hour urinary protein excretion >=0.5 g/day or urine protein-to-creatinine ratio (UPCR) >=0.4 g/g; (4) Estimated glomerular filtration rate (eGFR) >=25 mL/min/1.73 m^2; (5) Has received budesonide enteric-coated capsules at a dose of 16 mg for 9 months; (6) The subject and/or his/her legally authorized representative has signed the informed consent form (ICF) and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: 2. Exclusion criteria: Patients who meet any of the following exclusion criteria at screening will not be eligible to participate in this study: (1) Patients with secondary IgA nephropathy, such as IgA vasculitis, liver disease, or lupus; (2) Patients with concomitant other kidney diseases, such as diabetic nephropathy, tubulointerstitial kidney disease, membranous nephropathy, etc.; (3) Patients with minimal change disease presenting clinically as nephrotic syndrome with concomitant IgA deposition; (4) Patients with active infection, severe hepatic impairment (Child-Pugh class C), congestive heart failure, or a history of malignancy within the past 5 years, except for basal cell carcinoma of the skin; (5) Patients with known hypersensitivity to budesonide or any component of Nefecon, including serious hypersensitivity reactions, such as allergic reactions, previously occurring with other budesonide formulations; (6) Patients who received, within 4 weeks prior to treatment with budesonide enteric-coated capsules, any treatments including but not limited to systemic corticosteroids (e.g., prednisone, methylprednisolone), immunosuppressive therapy such as cyclophosphamide, cyclosporine, azathioprine, mycophenolic acid agents, calcineurin inhibitors, etc., or B-cell-targeted biological therapies such as telitacicept; (7) Female patients who are pregnant, breastfeeding, or planning to become pregnant; (8) Patients receiving strong CYP3A4 inhibitors; (9) Patients who, in the opinion of the investigator, are not suitable to continue treatment with budesonide enteric-coated capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinalysis;Random urine total protein/creatinine ratio;24-hour urine total protein;Serum galactose-deficient IgA1;Estimated glomerular filtration rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count;Glycated hemoglobin;Serum total bilirubin;Alanine aminotransferase;Glutamic oxalacetic transaminase;Alkaline phosphatase;Gamma-glutamyl transpeptidase;Sodium ;Potassium;Calcium;Phosphorus;Total serum protein;Serum albumin;Serum glucose;Serum creatinine;Serum urea nitrogen;Serum uric acid;Pregnancy tests; | — |
Countries
China
Contacts
Public ContactDong Xu
Second People's Hospital of Shenzhen
Outcome results
None listed