TruGraf Utilization in High IPV Levels

NCT04280276 | Terminated

• 1 other identifier: HP-00089343
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 2.800 patients, with approximately 50% of the patients being of African American heritage, thus an ideal setting for the study.

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• TruGraf test validity on immunosuppression damage

  The TruGraf test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.

  up to 18 months post-transplant

Secondary Outcomes (1)

• Renal function associated with premature graft loss

  up to 18 months post-transplant

Study Arms (2)

Group 1 - Patients with high IPV (designated as ≥ 30%).

ACTIVE COMPARATOR

Patients with high IPV (designated as ≥ 30%).

Diagnostic Test: TruGraf test

Group 2 - patients with normal IPV (< 30%).

ACTIVE COMPARATOR

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.

Diagnostic Test: TruGraf test

Interventions

TruGraf test DIAGNOSTIC_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.

Group 1 - Patients with high IPV (designated as ≥ 30%).; Group 2 - patients with normal IPV (< 30%).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are males or females of at least 18 years of age.
• Have the ability to understand the requirements of the study and are able to provide written informed consent.
• Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
• Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels)
• Kidney transplant patients who \>90 days (+/- 2 weeks) post-transplant will be included in this study
• Patients with at least 3 tacrolimus trough levels( deemed as appropriately 12-hour trough levels) within 3-36 months post-transplant

You may not qualify if:

• Inability or unwillingness to provide informed consent.
• Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
• Recipients of previous non-renal solid organ and/or islet cell transplantation.
• Infection with HIV.
• Infection with BK nephropathy.
• Patients that have nephrotic range proteinuria (urine protein \>3 gm/day).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Transplant Genomics, Inc.: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 21, 2020
• Study Start: March 2, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)