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Retrospective study of lyso-Gb3 plasma concentration in Fabry patients receiving ERT/Replagal

Not Applicable
Conditions
Fabry disease
Registration Number
JPRN-UMIN000017152
Lead Sponsor
Meiji Pharmaceutical University
Brief Summary

Clin Exp Nephrol. doi: 10.1007/s10157-017-1525-3.(open access)

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

The following patients should not be enrolled to the study; Patients who are considered ineligible for the study by the investigator

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
As a diagnostic bio-marker; 1) Plasma concentration of lyso-Gb3 2) Plasma concentration of lyso-Gb3 analogs (lyso-Gb3 [-2], lyso-Gb3 [+34] and other analogs) 3) GLA activity in plasma As a therapeutic bio-marker;; 1) Plasma concentration of lyso-Gb3 and the change from baseline in the concentration after initiation of the treatment with Replagal 2) Plasma concentration of lyso-Gb3 analogs (lyso-Gb3 [-2], lyso-Gb3 [+34]) and other analogs) after initiation of the treatment with Replagal, and the change from baseline in the analog concentration after initiation of the treatment with Replagal
Secondary Outcome Measures
NameTimeMethod
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