Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454110
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-06
Brief Title:
Study of NM8074 in Patients With Immunoglobulin A Nephropathy IgAN
Sponsor:
NovelMed Therapeutics
Organization:
NovelMed Therapeutics
Study Overview
Official Title:
A Phase II Open-Label Study of NM8074 in Patients With Immunoglobulin A Nephropathy IgAN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 Phase II open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment
Detailed Description:
The proposed study NM8074-IgAN-601 will enroll a planned total of 10 patients as subjects for the trial All subjects will be administered 17 mgkg of NM8074 intravenously every week for a total of 15 doses from Day 1 to Day 99 of the Treatment Period
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