To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease

Summary

Primary Objective: To assess reduction of plasma lyso-GL3 level after switch to agalsidase beta from agalsidase alfa Secondary Objectives: * To assess reduction of kidney podocyte GL3 content after switch to agalsidase beta from agalsidase alfa * To assess reduction of GL3 content in endothelial skin cells after switch to agalsidase beta from agalsidase alfa * To assess change in renal function after switch to agalsidase beta from agalsidase alfa * To assess disease severity and clinical changes after switch to agalsidase beta from agalsidase alfa * To assess improvement in symptoms of Fabry disease after switch to agalsidase beta from agalsidase alfa

Timeline

Start

2020-09

Primary completion

2023-11

Completion

2023-11

Outcome

Outcome not reported

Stopped (Enrollment): “The Sponsor terminated the study due to recruitment infeasibility without having enrolled any patient.”

Drugs

Indications