Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582485
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Trial to Assess Efficacy and Safety of Ex Vivo Allograft Admin of ICM012 Solution 2 Mgml to Improve Its Function in Recipients of DCD Kidneys
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Phase 2b Trial to Assess the Efficacy and Safety of Ex Vivo Allograft Admin of ICM012 Solution 2 MgmL to Improve Allograft Function in Recipients of Donation After Circulatory Death Kidneys
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized 11 placebo controlled double blind efficacy trial 200 patients will be followed up for 12 months post transplantation The primary endpoint will be Delayed Graft Function DGF defined as the requirement for dialysis within 7 days post transplantation
Detailed Description:
The present trial aims to evaluate if iCM012 solution 2 mgmL can improve short and mid-term allograft function of controlled donation after circulatory death DCD kidneys at high risk for Ischemia Reperfusion Injury IRI -induced graft dysfunction as assessed by primarily DGF and secondary as estimated glomerular filtration rates eGFR The trial will also generate additional efficacy safety and exploratory data
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