ISRCTN47722295
Active, not recruiting
Phase 4
An open-label study evaluating the efficacy and safety of budesonide in the treatment of patients with immunoglobulin A nephropathy
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institutul Clinic Fundeni
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37978255/ (added 20/11/2023)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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