Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02682407
Status:
UNKNOWN
Last Update Posted:
2020-04-10
First Post:
2016-02-10
Brief Title:
Safety Study of IgAN LN MN C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
Sponsor:
Omeros Corporation
Organization:
Omeros Corporation
Study Overview
Official Title:
A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy Lupus Nephritis Membranous Nephropathy or C3 Glomerulopathy Including Dense Deposit Disease
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
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:
The purpose of this study is to evaluate the safety and tolerability of OMS721 narsoplimab in subjects with Immunoglobulin A Nephropathy IgAN Lupus Nephritis LN Membranous Nephropathy MN and Complement Component 3 C3 Glomerulopathy including Dense Deposit Disease The study will also evaluate Pharmacokinetics PK Pharmacodynamics PD anti-drug antibody response ADA and neutralizing antibodies NAb of OMS721 when administered intravenously and when administered both intravenously and subcutaneously in subjects of Asian descent with IgA Nephropathy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None