Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02000440
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2013-11-27
Brief Title:
A Phase II Repeat Dose Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis FSGS
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study of Losmapimod to Reduce Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis FSGS
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This is a single-arm multicenter open-label Phase II proof-of-mechanism study to evaluate the efficacy safety tolerability and pharmacokinetics of losmapimod in approximately 21 subjects with primary idiopathic focal segmental glomerulosclerosis FSGS and substantive proteinuria as indicated by a Urinary proteincreatinine Upc ratio 2 gramgram gg or 24 hr urine protein 2 gday Losmapimod will be orally administered twice daily over a 24-week treatment phase followed by a 12-week follow-up for safety and relapse assessments
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