Personalized therapy for patients with IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sparsentan for IgA Nephropathy: safety and activity in adults with incident IgAN and recurrent IgAN after transplant

  This trial tests whether sparsentan can be safely given and help kidney outcomes in adults with immunoglobulin A nephropathy, including people newly diagnosed who haven’t had ACEI/ARB therapy and people with recurrent IgAN after kidney transplant.

  Recruiting at 6 sites Phase 2 University of Leicester · Cambridge, England and 5 other locations · NCT04663204

• Atrasentan for pediatric primary IgA nephropathy

  This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.

  Recruiting at 19 sites Phase 3 Novartis · Neptune City, New Jersey and 22 other locations · NCT07498335

• MIL116 for people with IgA nephropathy and healthy volunteers

  This trial will test whether subcutaneous MIL116, an anti‑APRIL antibody, is safe and how it behaves in the body in adults with IgA nephropathy and in healthy volunteers.

  Recruiting Phase 1/2 Beijing Mabworks Biotech Co., Ltd. · Beijing · NCT07375758

• Ravulizumab for children with IgA nephropathy or IgA vasculitis nephritis

  This trial will test whether intravenous ravulizumab is safe and changes disease markers in children aged 2 to under 18 with biopsy‑proven IgA nephropathy or IgA vasculitis nephritis.

  Recruiting at 13 sites Phase 3 Alexion Pharmaceuticals, Inc. · Palo Alto, California and 14 other locations · NCT07024563

• Mobile app to track symptoms and treatment in IgA nephropathy patients

  This study is testing a mobile app that helps people with IgA nephropathy track their symptoms and treatments to see how it affects their health and quality of life.

  Recruiting Novartis · Boston, Massachusetts · NCT06952426

• Effect of Daratumumab on Kidney Diseases Related to Monoclonal Gammopathy

  This study is testing whether daratumumab can help improve kidney function and overall health in people with kidney diseases linked to monoclonal gammopathy.

  Recruiting Phase 2 Helsinki University Central Hospital · Helsinki · NCT06889948

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.