Epidemiology of IgA Nephropathy: A Global Perspective.
Francesco Paolo Schena, Ionut Nistor
https://pubmed.ncbi.nlm.nih.gov/30177015Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID04662723
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.
Led by Fondazione Schena · Updated on 2025-04-02
878
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
Sponsors
F
Fondazione Schena
Lead Sponsor
U
University of Bari
Collaborating Sponsor
AI-Summary
What this Trial Is About
Idiopathic Immunoglobulin A nephropathy (IgAN) is the most common biopsy-confirmed glomerulonephritis worldwide, with about 40% of patients reaching end-stage kidney disease (ESKD) within 20 years. This trial investigates personalized therapy for IgAN patients by stratifying them based on kidney biopsy findings, serum creatinine, eGFR, and proteinuria to better target treatment. The study includes two randomized clinical trials (RCTs) evaluating different therapies based on the type of renal lesions and aims to assess whether personalized treatment can delay kidney function decline and ESKD onset. Patients with active renal lesions will be randomized to receive either corticosteroids combined with renin-angiotensin system blockers (RASBs) or RASBs followed by oral corticosteroids. Those with chronic or moderate renal lesions at high risk will be randomized to receive either a sodium-glucose cotransporter 2 inhibitor (SGLT2i) combined with RASBs or RASBs plus oral corticosteroids. Treatments include intravenous pulse methylprednisolone followed by oral prednisolone in some groups and titrated doses of RASBs or SGLT2i. The study also includes a molecular precision therapy component and uses an artificial intelligence tool (DialCheck) to predict ESKD risk and evaluate therapy impact. Participants will undergo regular visits over a follow-up period including clinical and laboratory assessments such as proteinuria, serum creatinine, eGFR, and blood pressure monitoring. Kidney biopsy results will guide therapy decisions, and adherence to medications and lifestyle recommendations like diet and exercise will be tracked. Outcomes measured include proteinuria reduction, eGFR slope changes, and composite kidney endpoints over 6 to 36 months. Safety monitoring includes watching for infections, glucose tolerance issues, weight gain, and hypoglycemia. The total study duration includes recruitment and follow-up extending up to several years.
CONDITIONS
Brief Title
Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Biopsy-proven idiopathic Immunoglobulin A nephropathy (IgAN)
- Presence of active, chronic, or moderate renal lesions related to IgAN
You will not qualify if you...
- Nephrotic syndrome or minimal change disease at kidney biopsy
- Hematuria with acute renal failure
- Rapidly progressive glomerulonephritis (extracapillary lesions in >50% of glomeruli)
- Secondary IgAN causes (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)
- Prior immunosuppressive therapy
- Superimposed IgAN in kidney transplant recipients
- Severe liver diseases
- Active infections
- Malignancies
- Pregnancy
- Recent myocardial infarction or cerebrovascular stroke (past 6 months)
- Uncontrolled diabetes
- Aseptic necrosis of any bone
- Conditions worsened by corticosteroids
- Previous adverse reactions to RASBs or SGLT2 inhibitors
- Mild renal lesions, minor urinary findings, proteinuria <0.5 g/day, normal GFR and blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months or longer depending on treatment arm and response
Participants receive personalized drug treatments based on kidney biopsy results. Those with active renal lesions may receive corticosteroids combined with renin-angiotensin system blockers (RASBs) or RASBs alone initially. Those with chronic or moderate renal lesions may receive a sodium-glucose cotransporter 2 inhibitor (SGLT2i) combined with RASBs or RASBs followed by corticosteroids. Treatments are administered for approximately 3 months with adjustments based on response and proteinuria levels.
Regular visits at prescribed times during treatment to collect clinical and laboratory data and assess drug adherence
Follow-up
Duration - Up to 36 months after treatment initiation
Participants continue to be monitored through regular outpatient visits to assess renal function, proteinuria, and other health parameters, including safety monitoring for adverse events and adherence to lifestyle recommendations such as diet and exercise.
Multiple follow-up visits over 3 years including a final outpatient visit
Trial Site Locations
Total: 2 locations
1
francesco paolo Schena
Bari, BA, Italy, 70124
Actively Recruiting
2
francesco paolo Schena
Bari, BA, Italy, 70124
Actively Recruiting
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Research Team
F
Francesco P Schena
F
francesco P Schena
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Natural history and risk factors for immunoglobulin A nephropathy in Japan. Research Group on Progressive Renal Diseases.
A Koyama, M Igarashi, M Kobayashi
https://pubmed.ncbi.nlm.nih.gov/9100040A novel simpler histological classification for renal survival in IgA nephropathy: a retrospective study.
Carlo Manno, Giovanni F M Strippoli, Christian D'Altri...
https://pubmed.ncbi.nlm.nih.gov/17533019Chapter 10: Immunoglobulin A nephropathy.
https://pubmed.ncbi.nlm.nih.gov/25018935Development and testing of an artificial intelligence tool for predicting end-stage kidney disease in patients with immunoglobulin A nephropathy.
Francesco Paolo Schena, Vito Walter Anelli, Joseph Trotta...
https://pubmed.ncbi.nlm.nih.gov/32889014The Oxford classification of IgA nephropathy: pathology definitions, correlations, and reproducibility.
Working Group of the International IgA Nephropathy Network and the Renal Pathology Society, Ian S D Roberts, H Terence Cook...
https://pubmed.ncbi.nlm.nih.gov/19571790The Oxford classification of IgA nephropathy: rationale, clinicopathological correlations, and classification.
Working Group of the International IgA Nephropathy Network and the Renal Pathology Society, Daniel C Cattran, Rosanna Coppo...
https://pubmed.ncbi.nlm.nih.gov/19571791The Oxford classification as a predictor of prognosis in patients with IgA nephropathy.
Seok Hui Kang, Sun Ryoung Choi, Hoon Suk Park...
https://pubmed.ncbi.nlm.nih.gov/21606384Intensive Supportive Care plus Immunosuppression in IgA Nephropathy.
Thomas Rauen, Frank Eitner, Christina Fitzner...
https://pubmed.ncbi.nlm.nih.gov/26630142Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial.
Jicheng Lv, Hong Zhang, Muh Geot Wong...
https://pubmed.ncbi.nlm.nih.gov/28763548