Status:
RECRUITING
Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.
Lead Sponsor:
Fondazione Schena
Collaborating Sponsors:
University of Bari
Conditions:
Glomerulonephritis
Immunoglobulin A Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Idiopathic immunoglobulin A nephropathy (IgAN) is the most common biopsy-proven glomerulonephritis in the world. Approximately 40% of IgAN patients reach end-stage kidney disease (ESKD) 20 years after...
Detailed Description
BACKGROUND AND RATIONALE. Idiopathic Immunoglobulin A nephropathy (IgAN) is the most common biopsy-proven glomerulonephritis in the world. It is more prevalent in Asia than in Europe and the US. Appro...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.
- IgAN patients with active or chronic or moderate renal lesions
- Exclusion Criteria
- Patients with idiopathic IgAN and nephrotic syndrome (minimal change disease at kidney biopsy)
- IgAN patients with hematuria and acute renal failure
- IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 50% of glomeruli)
- Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)
- Any prior immunosuppressive therapy
- Superimposed IgAN in kidney transplant
- Severe liver diseases
- Infections
- Malignancies
- Pregnancy
- Patients with myocardial infarction or cerebrovascular stroke in the previous 6 months
- Uncontrolled diabetes
- Aseptic necrosis of any bone
- Other conditions that can be exacerbated by corticosteroids
- Previous adverse side effects to RASBs
- Previous adverse side effects to SGLT2is
- Patients with mild renal lesions (M0,E0,S0,T0,C0), minor urinary findings, proteinuria \< 0.5 g/day, normal GFR and normal blood pressure
Exclusion
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
878 Patients enrolled
Trial Details
Trial ID
NCT04662723
Start Date
May 1 2023
End Date
December 31 2028
Last Update
April 2 2025
Active Locations (2)
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1
francesco paolo Schena
Bari, BA, Italy, 70124
2
francesco paolo Schena
Bari, BA, Italy, 70124