Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
NCT00837824 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2015-04-07
Summary
This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.
Conditions
- Fabry Disease
- Chronic Kidney Disease, Stage IV (Severe)
Interventions
- BIOLOGICAL
-
Fabrazyme (agalsidase beta)
1.0 mg/kg every 2 weeks
- BIOLOGICAL
-
Fabrazyme (agalsidase beta)
3.0 mg/kg every 2 weeks
Sponsors & Collaborators
-
CRL/Medinet
collaborator UNKNOWN -
Genzyme, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Genzyme, a Sanofi Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-12-31
- Primary Completion
- 2003-08-31
- Completion
- 2003-08-31
Countries
- United States
Study Locations
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