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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00312767 |
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Date of registration:
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07/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.
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Scientific title:
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A Multicenter, Open-Label, Cross-Over Trial to Evaluate the Pharmacokinetics of Fabrazyme During Simultaneous Fabrazyme Infusion and Chronic Hemodialysis in Patients With Fabry Disease. |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00312767 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient must provide signed, written informed consent prior to any study-related
procedures being performed.
- Patient is between 18 and 65 years of age, inclusive.
- Patient has documented Fabry disease.
- Patient has received bi-weekly 1 mg/kg infusions of Fabrazyme for at least 6 months
prior to enrollment into the study.
- Patient has not experienced moderate or severe infusion-associated reactions (IARs)
from Fabrazyme infusions, which were also associated with a rate reduction, within 3
months prior to enrollment into the study.
- Patient has been receiving chronic hemodialysis for treatment of end-stage renal
insufficiency for at least 3 months prior to enrollment into the study.
- Patient has good vascular access for hemodialysis.
- Patient has not and will not have any other (investigational) drug(s) infused during
their hemodialysis, and is expected to have a stable concomitant medication regimen
at all PK assessments.
Exclusion Criteria:
- Patient's hemoglobin is < 9 g/100 mL at Screening/Baseline.
- Patient has a clinically significant organic disease or an unstable condition that,
in the opinion of the Investigator, would preclude participation in the study.
- Patient has a medical condition, serious intercurrent illness, or extenuating
circumstance that would significantly decrease study compliance.
- Patient has participated in a study employing an investigational drug within 30 days
prior to the start of their participation in this study.
- Patient is unwilling to comply with the requirements of the protocol.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fabry Disease
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Intervention(s)
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Drug: Fabrazyme (agalsidase beta)
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Primary Outcome(s)
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Verify that no loss of Fabrazyme occurs during simultaneous Fabrazyme infusion and hemodialysis with a low-flux membrane.
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Secondary Outcome(s)
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Verify that no loss of Fabrazyme occurs during simultaneous Fabrazyme infusion and hemodialysis with a high-flux membrane.
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Secondary ID(s)
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AGAL03505
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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