The Role of TruGraf to Optimize Outcomes in Pediatric Renal Transplantation

Project Summary

The purpose of this study is to determine how the TruGraf blood test, TRAC blood test, and CXCL10 protein urine test detect graft rejection compared to results from standard clinical kidney biopsy tissue testing in pediatric patients. Peripheral blood samples and urine collected at the time of routine clinical biopsies will undergo biomarker testing as apart of this study. Data collected for this study will include demographics, transplant information, medications, lab results, and biopsy information. This study will enroll 75 participants across all sites with approximately 25 participants enrolled at BC Children's Hospital.

This is a three-center pilot prospective study being conducted by Dr. Tom Blydt-Hansen's research team at BC Children's Hospital Research Institute along with two other study sites. Dr. Tom Blydt-Hansen is the principal investigator.

Project Status

Status: Recruiting
Study Start Date: January 5, 2022
Study End Date: August 1, 2023

Study Enrollment Status: Active, data collection ongoing
Study Start Date: January 5, 2022
Study End Date: August 1, 2023

Project Team

Principal Investigator

Tom Blydt-Hansen

Research Team Members

Candice Wiedman, Research Assistant
Hyunwoong Chae, Research Assistant
Monica Ho, Research Coordinator

Enrollment Eligibility Criteria
  1. Serum creatinine at the time of the clinic visit prior to the scheduled biopsy within 30% of a baseline calculated as the mean of the recipient’s last 3 serum creatinine levels
  2. Serum creatinine level at the time of protocol biopsy ≤ 1.7mg/dl.
  3. Patient receiving immunosuppression with a calcineurin inhibitor (either tacrolimus or cyclosporine) and/or an antimetabolite (either mycophenolate mofetil, mycophenolic acid EC or azathioprine) and/or an mTOR inhibitor (either sirolimus or everolimus) and/or corticosteroids.
  4. Absence of any systemic or urinary bacterial, viral or fungal infection
  5. Absence of significant BK viremia (as determined by the laboratory where the determination is run) at the time of the last clinical determination and at the time of the protocol biopsy
  6. Patient has previously consented to the HOPE SOT and Biobanking for SOT research studies.

For more information, or if you are interested in participating, contact