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
The study will have a screening period of up to 9 weeks. Eligible participants will be randomized to switch to agalsidase beta or to continue agalsidase alfa in a 1:1 ratio for a period of 12 months (52 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Pharmaceutical form:Powder for concentrate for solution for infusion Route of administration: Intravenous (IV) infusion,
Pharmaceutical form:concentrate for solution for infusion Route of administration: Intravenous (IV) infusion
Change in Plasma globotriaosylsphingosine (lyso-GL3) level
Change from baseline to 12 months (week 52) for plasma lyso-GL3 level
Time frame: Baseline, 12 months (week 52)
Change in GL3 content in podocytes
Change from baseline to 12 months (week 52) for GL3 content in podocytes
Time frame: Baseline, 12 months (week 52)
Change in GL3 content in endothelial skin cells
Change from baseline to 12 months (Week 52) for GL3 content in endothelial skin cells
Time frame: Baseline, 12 months (week 52)
Change in measured glomerular filtration rate (mGFR)
Change from baseline to 12 months (Week 52) for measured glomerular filtration rate (mGFR) (measured by iohexol clearance)
Time frame: Baseline, 12 months (week 52)
Change in estimated glomerular filtration rate (eGFR) calculated
Change from baseline to 12 months (Week 52) for estimated glomerular filtration rate (eGFR) calculated using age appropriate formula \[Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)/ Bedside-Schwartz\]
Time frame: Baseline, 12 months (week 52)
Change in Mainz Severity Score Index (MSSI) total score
Change from baseline to 12 months (Week 52) for Mainz Severity Score Index (MSSI), based on MSSI total score
Time frame: Baseline, 12 months (week 52)
Change in Fabry Disease Patient Reported Outcomes (FD-PRO) total symptom score
Change from baseline to 12 months (Week 52) in Fabry Disease Patient Reported Outcomes (FD-PRO) score, based on FD-PRO total symptom score
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Time frame: Baseline, 12 months (week 52)