Personalized therapy for patients with IgA nephropathy
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.
This study is testing if personalized treatment plans can help people with IgA nephropathy feel better and lower their chances of serious kidney problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 878 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Schena Academic / other |
| Locations | 2 sites (Bari, BA and 1 other locations) |
| Trial ID | NCT04662723 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of personalized therapy for patients diagnosed with idiopathic immunoglobulin A nephropathy (IgAN), a common form of glomerulonephritis. The approach involves stratifying patients based on the type of renal lesions observed during kidney biopsy, alongside clinical parameters like estimated glomerular filtration rate (eGFR) and proteinuria. By tailoring treatment with corticosteroids, renin-angiotensin system blockers, and sodium-glucose cotransporter 2 inhibitors, the study aims to improve patient outcomes and reduce the risk of end-stage kidney disease. The study is multicenter, prospective, controlled, and open-label, ensuring a comprehensive evaluation of personalized treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18-70 with biopsy-proven idiopathic IgAN who have active or chronic renal lesions.
Not a fit: Patients with nephrotic syndrome, rapidly progressive glomerulonephritis, or secondary IgAN, among other specified conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and individualized treatment options for patients with IgA nephropathy, potentially reducing the progression to end-stage kidney disease.
How similar studies have performed: Previous studies have shown promise in personalized treatment approaches for IgAN, but this specific stratification method based on renal lesions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bari, BA and 1 other locations
- francesco paolo Schena — Bari, Ba, Italy (Recruiting)
- francesco paolo Schena — Bari, Ba, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco P Schena
- Email: paolo.schena@uniba.it
- Phone: 3336771291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.