Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02090608
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2014-03-14
Brief Title:
Paricalcitol in Fabry Disease
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Proteinuria is the predominant risk factor for renal disease progression in Fabry disease FD When urine protein excretion is controlled to 050 g24 hr the rate loss of glomerular filtration rate GFR is not significantly different from 0 However enzyme replacement therapy ERT alone does not decrease proteinuria and it has been recommended that patients receiving ERT also receive anti Renin-Angiotensin-System RAS therapy Emerging evidences show that paricalcitol PCT reduces proteinuria in presence of intensified inhibition of RAS however there is no evidence in FD The aim of this study is to evaluate the antiproteinuric effect of PCT in FD patients with proteinuria 050 g24 hr persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None