Ignite Creation Date:
2025-12-18 @ 8:55 AM
Ignite Modification Date:
2025-12-23 @ 9:58 PM
Study NCT ID:
NCT04280276
Status:
None
Last Update Posted:
2024-12-16 00:00:00
First Post:
2020-02-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TruGraf Utilization in High IPV Levels
Sponsor:
None
Organization:
Study Overview
Official Title:
Utilizing TruGraf Testing in Recipients of Kidney Transplantation With High Intra-patient Variability in Tacrolimus Exposure: A Pilot Study
Status:
None
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor, TGI, was acquired by Eurofins Inc. New owner requested all IIT's be terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Population: Kidney transplant recipients with stable renal function with regular follow-up at the University of Maryland post-transplant clinic with at least 3 levels deemed as appropriately 12-hour trough levels within 3-36 months post-transplant.
Group 1 - patients with high IPV (designated as ≥ 30%). Group 2 - patients with normal IPV (\< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.
Calculation of IPV: CV (%) = (SD/mean Tac trough concentration) x 100 (if stable total daily dose). To take into account dose changes, obtained levels will be corrected for the corresponding daily dose of tacrolimus to help correctly calculate IPV (CV C0/D-IPV) (6-7).
Patients will be tested with TruGraf one time during the study.
Group 1 - patients with high IPV (designated as ≥ 30%). Group 2 - patients with normal IPV (\< 30%). Will assess risk of subclinical acute rejection in patients with high IPV compared to normal IPV. All tacrolimus 12 h trough levels in patients with stable allograft function at least 3 months post-transplant.
Calculation of IPV: CV (%) = (SD/mean Tac trough concentration) x 100 (if stable total daily dose). To take into account dose changes, obtained levels will be corrected for the corresponding daily dose of tacrolimus to help correctly calculate IPV (CV C0/D-IPV) (6-7).
Patients will be tested with TruGraf one time during the study.
Detailed Description:
None
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?: