Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fabry Disease Chronic Kidney Disease, Stage IV (Severe)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fabrazyme 1mg/kg every 2 weeks

Fabrazyme 1.0 mg/kg every 2 weeks

Group Type EXPERIMENTAL

Fabrazyme (agalsidase beta)

Intervention Type BIOLOGICAL

1.0 mg/kg every 2 weeks

Fabrazyme 3mg/kg every 2 weeks

Fabrazyme 3.0 mg/kg every 2 weeks

Group Type EXPERIMENTAL

Fabrazyme (agalsidase beta)

Intervention Type BIOLOGICAL

3.0 mg/kg every 2 weeks

Interventions

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Fabrazyme (agalsidase beta)

1.0 mg/kg every 2 weeks

Intervention Type BIOLOGICAL

Fabrazyme (agalsidase beta)

3.0 mg/kg every 2 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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r-hαGAL r-hαGAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No