Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04280276
Status:
TERMINATED
Last Update Posted:
2022-03-31
First Post:
2020-02-11
Brief Title:
TruGraf Utilization in High IPV Levels
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Utilizing TruGraf Testing in Recipients of Kidney Transplantation With High Intra-patient Variability in Tacrolimus Exposure A Pilot Study
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor TGI was acquired by Eurofins Inc New owner requested all IITs be terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intra-patient variability IPV in tacrolimus is associated with premature graft loss The rate of acute rejection episodes is higher in these patients and acute rejection impacts negatively on graft survival The prevalence of patients with high IPV is higher in African American patients 1-5 At the kidney transplant program of the University of Maryland our investigators follow over 2800 patients with approximately 50 of the patients being of African American heritage thus an ideal setting for the study
Detailed Description:
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 SDmean 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 C0D-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 SDmean 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 C0D-IPV 6-7
Patients will be tested with TruGraf one time during the study
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