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Abstract #0406

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

Yuehong Liu1, Meiling Jin2, Hui Li1, Xinyu Wang1, Chen Zhang3, Jing An4, Qianmei Sun2, Ning Gu5, and Qi Yang1
1Department of Radiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China, 2Department of Nephrology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China, 3MR Scientific Marketing, Siemens Healthcare, Beijing, China, 4Siemens Shenzhen Magnetic Resonance Ltd., Shenzhen, China, 5Medical School of Nanjing University, Nanjing, China

Synopsis

Keywords: Contrast Agents, Vessels

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.

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