Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT04143958
Brief 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
Detailed Description:
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:
NCT04143958
Study Brief:
Protocol Section:
NCT04143958