Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312767
Status:
WITHDRAWN
Last Update Posted:
2014-02-05
First Post:
2006-04-07
Brief Title:
A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Open-Label Cross-Over Trial to Evaluate the Pharmacokinetics of Fabrazyme During Simultaneous Fabrazyme Infusion and Chronic Hemodialysis in Patients With Fabry Disease
Status:
WITHDRAWN
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with Fabry disease have an alteration in their genetic material DNA which causes a deficiency of the a-galactosidase A enzyme Fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called glycolipids These glycolipids are normally present within the body in most cells In Fabry disease glycolipids build up in various tissues such as the liver kidney skin and blood vessels because a-galactosidase A is not present or is present in small quantities The build up of glycolipid globotriaosylceramide or GL-3 levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease This study is designed to verify that no loss of Fabrazyme occurs during simultaneous Fabrazyme infusion and hemodialysis in patients currently receiving Fabrazyme at a dose of 10 mgkg every 2 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None