Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Kidney Transplant; Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04280276
Collaborators
Transplant Genomics, Inc.
Investigators
Not Provided