Status:
TERMINATED
Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
Lead Sponsor:
Genzyme, a Sanofi Company
Collaborating Sponsors:
CRL/Medinet
Conditions:
Fabry Disease
Chronic Kidney Disease, Stage IV (Severe)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- provided written informed consent prior to any study-related procedures being performed.
- be ≥16 years old.
- have a current diagnosis of Fabry disease (defined as abnormal α-galactosidase (α GAL) enzyme levels or Fabry genotype).
- have one of the following clinical conditions present at enrollment: serum creatinine level greater than 3.0 mg/dL (an average of two values at least one week apart), or be currently on dialysis, or be status post kidney transplant by greater than 3 months.
- have the ability to comply with the requirements of the protocol
- have a negative pregnancy test, if a female patient of childbearing potential. In addition, all female patients of childbearing potential must use a medically accepted method of contraception throughout the study.
Exclusion
- if they did not meet the specific inclusion criteria.
- if they had participated in a study employing an investigational drug within 30 days of the start of their participation in this trial.
- had previously received enzyme replacement therapy (ERT) for their Fabry disease.
- had diabetic nephropathy.
- were pregnant or lactating.
- were unwilling to comply with the requirements of the protocol.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00837824
Start Date
December 1 2002
End Date
August 1 2003
Last Update
April 7 2015
Active Locations (9)
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1
Farmington, Connecticut, United States
2
Coral Springs, Florida, United States
3
Kansas City, Kansas, United States
4
Boston, Massachusetts, United States