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TRULO


Title TruGraf® Long-term Clinical Outcomes Study
Therapeutic Area Kidney Transplantation
Principal Investigator Nitender Goyal
Min Age 18 Years
Gender All
Contact Laura Diamond
617-636-2571
ldiamond@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04491552

Overview

This is a prospective, multi-center, observational study. Subjects will have TruGraf® and TRAC™ testing at study enrollment and thereafter every 3 months. In addition subjects will have TRAC™ testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Study Details

Inclusion Criteria

  • Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
  • At least 1-year post-transplant (+/- 2 months);
  • Stable serum creatinine (current serum creatinine < 2.3 mg/dl, < 20% increase compared to the average of the previous 3 serum creatinine levels)

Exclusion Criteria

  • Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;=
  • Recipient of a previous non-renal solid organ and/or islet cell transplant;=
  • Known to have nephrotic proteinuria (urine protein > 3 gm/day)

Study Requirements

Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection. This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.