IgA Nephropathy
Conditions
Interventions
Observation group:N/A
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study participants eligible for enrollment must meet all of the following criteria: (1) A confirmed diagnosis of primary IgA nephropathy via renal biopsy, with a MEST-C score indicating S=1; (2) Presence of risk factors for disease progression: In accordance with the KDIGO 2025 Clinical Practice Guideline for the Management of IgA Nephropathy (where disease progression is primarily characterized by a sustained decline in eGFR over time, and proteinuria is currently the only validated early surrogate marker for assessing progression risk), this study includes patients with a baseline 24-hour urinary protein quantification of >=0.5 g/day or an eGFR <60 mL/min/1.73 m^2. (3) First-time use of budesonide enteric capsules at our hospital, with a follow-up duration of =3 months.
Exclusion criteria
Exclusion criteria: Study participants who meet any of the following criteria are not eligible for enrollment in this study: (1) Patients with secondary IgA nephropathy (e.g., IgA vasculitis, hepatitis-associated nephropathy, etc.); (2) Patients with severe hepatic impairment (Child-Pugh Class C); (3) Patients with a known hypersensitivity to budesonide enteric capsules; (4) Patients with severe coagulation disorders who have not undergone a renal biopsy (unless their clinical and laboratory findings are highly suggestive of a diagnosis of IgA nephropathy); (5) Special populations: children, adolescents, and pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24h of urine protein;Improvement in proteinuria;Stable renal function;Improvement in hematuria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine;Quality of Life improvement;Drug tolerance; | — |
Countries
China
Contacts
Public ContactShu Rong
Shanghai General Hospital
Outcome results
None listed