Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme

NCT00837824 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-07

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837824 on ClinicalTrials.gov