NCT04280276

TruGraf Utilization in High IPV Levels

Utilizing TruGraf Testing in Recipients of Kidney Transplantation With High Intra-patient Variability in Tacrolimus Exposure: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 2.800 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 (%) = (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.

Conditions

• Kidney Transplant; Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TruGraf test	To obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic.

Timeline

• Start date: 2020-03-02
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2020-02-21
• Last updated: 2024-12-16

Locations

1 site across 1 country: United States