Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme

Stopped early · Phase 2

Conditions studied: Fabry Disease, Chronic Kidney Disease, Stage IV (Severe)

In brief

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.

Key facts

Study ID

NCT00837824

Run by

Genzyme, a Sanofi Company

People needed

20

Starts

2002-12-01

Expected to finish

2003-08-01

Last updated by the study team

2015-04-07

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Farmington, Connecticut, United States
• Study site — Coral Springs, Florida, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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