Multicentre Open-Label Study of Personalized Therapy Using Corticosteroids, RASBs, and SGLT2 Inhibitors in Adults with Immunoglobulin A Nephropathy

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.

Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.