Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-12-08
Brief Title:
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease REPAIR
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease REPAIR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Phase 1 basket trial including 2 open-label single-arm cohorts REPAIR CKD cohort and REPAIR Dialysis cohort Open label colchicine 03 mg daily for 8 weeks followed in patients who tolerated the 03 mg dose by forced titration to 06 mg daily for 8 weeks
Detailed Description:
The REPAIR CKD cohort will enroll 100 patients with chronic kidney disease not requiring dialysis The REPAIR Dialysis cohort will enroll 100 patients with chronic kidney disease requiring chronic maintenance dialysis Each participant will be followed for up to 17 weeks to determine among adults with severe chronic kidney disease not requiring dialysis and separately in those requiring dialysis the proportion who over 8 weeks of treatment discontinue colchicine 1 03 mg daily and 2 06 mg daily
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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