Efficacy and Safety of Generic Ferumoxytol for Whole-Body MRA in Patients with Chronic Kidney Disease: A Dose-Optimization Clinical Trial

Motivation: Generic ferumoxytol produced in China holds promise in addressing the challenges of evaluating polyvascular disease in patients with chronic kidney disease (CKD). However, its dose-related efficacy and safety as an contrast agent for MR angiography (MRA) in CKD patients require clarification. Goal(s): To investigate the optimal dose of a generic ferumoxytol for 3T whole-body MRA in CKD patients. Approach: This prospective, open-label, dose-optimization trial assessed image quality and safety in CKD patients receiving escalating doses (1-4 mg/kg) of generic ferumoxytol. Results: The 3 mg/kg dose was optimal, demonstrating non-inferiority to the 4 mg/kg dose with a comparable 90-day safety profile. Impact: This study provides a cost-effective dosing regimen for future Phase III trials and for the clinical screening of polyvascular diseases in CKD patients.