Stabilization of kidney function in patients diagnosed with primary immunoglobulin A nephropathy by treatment with a locally-acting corticosteroid formulation – budesonide

Phase 4

• Conditions: Immunoglobulin A nephropathy; Urological and Genital Diseases

• Registration Number: ISRCTN47722295
• Lead Sponsor: Institutul Clinic Fundeni

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37978255/ (added 20/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-14
• Last Update Posted: 4 December 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified