Status:
WITHDRAWN
A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Fabry Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- Patient must provide signed, written informed consent prior to any study-related procedures being performed.
- Patient is between 18 and 65 years of age, inclusive.
- Patient has documented Fabry disease.
- Patient has received bi-weekly 1 mg/kg infusions of Fabrazyme for at least 6 months prior to enrollment into the study.
- Patient has not experienced moderate or severe infusion-associated reactions (IARs) from Fabrazyme infusions, which were also associated with a rate reduction, within 3 months prior to enrollment into the study.
- Patient has been receiving chronic hemodialysis for treatment of end-stage renal insufficiency for at least 3 months prior to enrollment into the study.
- Patient has good vascular access for hemodialysis.
- Patient has not and will not have any other (investigational) drug(s) infused during their hemodialysis, and is expected to have a stable concomitant medication regimen at all PK assessments.
Exclusion
- Patient's hemoglobin is \< 9 g/100 mL at Screening/Baseline.
- Patient has a clinically significant organic disease or an unstable condition that, in the opinion of the Investigator, would preclude participation in the study.
- Patient has a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance.
- Patient has participated in a study employing an investigational drug within 30 days prior to the start of their participation in this study.
- Patient is unwilling to comply with the requirements of the protocol.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00312767
Start Date
April 1 2006
Last Update
February 5 2014
Active Locations (1)
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1
Trident Nephrology Associates
North Charleston, South Carolina, United States, 29405