Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genzyme, a Sanofi Company
With
CRL/Medinet
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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.
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.
