Primary IgA nephropathy
Conditions
Interventions
Test group (nefecon+Mycophenolate mofetil):None
Sponsors
The first affiliated hostipal of nanchang university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients aged >= 18 years old; 2) Diagnosed with immunoglobulin A nephropathy (IgAN) through biopsy within the past 10 years; 3) Willing and able to provide written informed consent during screening; 4) Based on informed consent and two consecutive measurements (24-hour urine sampling) of proteinuria, with an interval of at least 2 weeks, calculated by the central laboratory. Two samples with the same parameter must display either of the following: In two consecutive measurements, proteinuria >= 1 g/day (>= 1000 mg/day) or urinary protein creatinine ratio (UPCR) >= 0.75g/g, and proteinuria 24-hour UTP= 30mL/min/1.73 m2, with an interval of at least 2 weeks, calculated by the central laboratory.
Exclusion criteria
Exclusion criteria: 1.Systemic diseases that may lead to the deposition of mesangial immunoglobulin A (IgA), including but not limited to allergic purpura, systemic lupus erythematosus, herpetic dermatitis, ankylosing spondylitis, etc. 2) Combined with other kidney diseases, such as diabetes nephropathy, C3 glomerular disease, nephrotic syndrome, etc; 3) Active infection, severe liver dysfunction (Child Pugh C grade), congestive heart failure, and malignant tumors other than basal cell carcinoma within 5 years 4) Allergies to any ingredient in budesonide or budesonide enteric coated capsules, including severe hypersensitivity reactions including allergic reactions, have occurred when using other budesonide formulations 5) Budesonide enteric coated capsules should be used within 4 weeks before treatment, including but not limited to systemic hormone therapy (prednisone, methylprednisolone, etc.), immunosuppressive therapy (cyclophosphamide, cyclosporine, azathioprine, mycophenolic acid, calcineurin inhibitors, etc.), and biologic therapy targeting B cells (tacrolizumab, etc.); 6) Pregnant and lactating female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease in UPCR compared to baseline at 9 and 12 months after treatment;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in eGFR compared to baseline;Changes in UPCR at each visit compared to baseline.;Changes in the proportion of patients without hematuria at each visit compared to baseline;Incidence of adverse events; | — |
Countries
China
Contacts
Public Contactweixin
The first affiliated hostipal of nanchang university
Outcome results
None listed