Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02090608
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paricalcitol in Fabry Disease
Sponsor:
Federico II University
Organization:
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 \<0.50 g/24 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 \>0.50 g/24 hr persisting despite the ERT and anti-RAS therapy titrated to maximum tolerated dosage.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: