Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease

What this Trial Is About

This trial evaluates the long-term effects and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy compared to low-dose corticosteroids alone, all given alongside maximum tolerated RAS inhibitor therapy. It focuses on adults with IgA nephropathy who have stage 3 or 4 chronic kidney disease, aiming to better understand treatment options for this kidney condition. The study is a Phase 3 clinical trial sponsored by the Air Force Military Medical University in China. Participants are randomly assigned to one of two treatment groups: one receives low-dose corticosteroids alone, while the other receives low-dose corticosteroids combined with cyclophosphamide. Both groups continue to receive RAS blockade therapy at the highest tolerated dose. Treatments are given orally, and the study will observe participants for up to six years to compare the therapies' effects. During the trial, researchers will monitor participants' kidney function, proteinuria, and hematuria at multiple time points, including 6 and 12 months and throughout the follow-up period. Various kidney health outcomes such as decreases in estimated glomerular filtration rate (eGFR), progression to end-stage renal disease (ESRD), and overall survival will be assessed. Safety and long-term efficacy are key focuses, with participants being followed for up to six years to track these outcomes.

Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD