Immunoglobulin A nephropathy Urological and Genital Diseases Immunoglobulin A nephropathy
Conditions
Interventions
Patients receive treatment with budesonide at a dose of 9 mg/day for the first 12 months, subsequently tapered to 3 mg/day for another 12-24 months.
Sponsors
Institutul Clinic Fundeni
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Patients with a histological diagnosis of IgA nephropathy 3. Patients with primary IgA nephropathy 4. Patients with persistent proteinuria over 1g/day despite adequate renin-angiotensin-aldosterone system (RAAS) blockade or patients with proteinuria between 0.5 and 1 g/day after RAAS blockade if they had additional risk factors for progression (estimated glomerular filtration rate below 60 ml/min/1.73m², presence of proliferative lesions on kidney biopsy)
Exclusion criteria
Exclusion criteria: 1. IgAN associated with other disorders (viral infections, autoimmune disorders, malignancy) 2. Estimated glomerular filtration rate below 20 ml/min/1.73m² 4. Nephrotic syndrome or a rapidly progressive clinical course 5. Proteinuria below 0.5 g/day after adequate RAAS blockade. 6. Severe histological lesions of activity or chronicity (endocapillary hypercellularity in over 50% of examined glomeruli, crescents in over 30% of examined glomeruli, presence of fibrinoid necrosis, global glomerulosclerosis in over 50% of examined glomeruli) 7. Diabetes mellitus or active infections 8. Received prior immunosuppression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline and 36 months: 1. Estimated glomerular filtration rate 2. Extent of proteinuria and hematuria 3. MESTC score assessed by kidney biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of budesonide-related adverse events over the 36 months | — |
Countries
Romania
Outcome results
None listed