Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601155
Status:
COMPLETED
Last Update Posted:
2023-11-03
First Post:
2020-09-10
Brief Title:
Transition of Renal Patients Using AlloSure Into Community Kidney Care
Sponsor:
CareDx
Organization:
CareDx
Study Overview
Official Title:
Transition of Renal Patients Using AlloSure Into Community Kidney Care
Status:
COMPLETED
Status Verified Date:
2023-11
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:
TRACK
Brief Summary:
Patients undergoing kidney transplantation alone either de-novo or re-transplant at a participating hospital are routinely surveyed with interval blood tests as part of standard post-operative care through outpatient consultation These tests include serum creatinine blood sugar as well as DSA testing at various intervals The ability to screen patients to better identify those who may be at risk of developing an adverse event using AlloSure cfDNA is likely to be advantageous with the potential to improve graft survival and outcomes for transplant patients The addition of AlloSure to the interventional group will be the focus of this study Patients will have quarterly AlloSure cfDNA testing every 3 months and DSA as part of their post-transplant surveillance for a period of 5 yearsParticipants will attend outpatient visitsfollow-up visits as part of their standard care these will include appointments where they will have blood tests taken as part of post-transplant surveillance For AlloSure cfDNA and DSA blood will be taken quarterly
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None