IgA nephropathy
Conditions
Interventions
Observation group:None
Sponsors
Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with primary IgA nephropathy through renal biopsy; 2. Age>= 18 years; 3. 24-hour urine protein quantification > 0.5g/d or urine protein to creatinine ratio (UPCR) > 0.4g/g; 4. Estimated glomerular filtration rate (eGFR) >= 25ml/min/1.73m^2; 5. Currently receiving or planning to receive treatment with Nefecon; 6. The subject or (and) their legal guardian has signed the informed consent form (ICF) and is willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with secondary IgA nephropathy due to conditions such as IgA vasculitis, liver disease, lupus, etc.; 2. Patients with other kidney diseases such as diabetic nephropathy, tubulointerstitial nephropathy, membranous nephropathy, etc.; 3. Patients with minimal change nephropathy presenting with nephrotic syndrome and IgA deposition; 4. Active infections, severe liver dysfunction (Child-Pugh C grade), congestive heart failure, and a history of developing malignant tumors other than basal cell carcinoma within 5 years; 5. Allergic to any component of budesonide or budesonide enteric-coated capsules, including severe hypersensitivity reactions that occurred during the use of other budesonide formulations; 6. Within 4 weeks before Nefecon enteric-coated capsule treatment, use of systemic hormone therapy (prednisone, methylprednisolone, etc.), immunosuppressive therapy: cyclophosphamide, cyclosporine, azathioprine, mycophenolic acid, calcineurin inhibitors, etc., targeted B-cell biological therapy: tixocortol, etc.; 7. Pregnant and lactating female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage reduction in 24-hour proteinuria at 12 months compared to the baseline level;Galactose-deficient IgA1;Plasma polymeric IgA;IgA-IgG immune complex;Glomerular filtration rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine protein-to-creatinine ratio; | — |
Countries
China
Contacts
Public ContactYuan Cheng
Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University
Outcome results
None listed