Kidney Transplant Rejection
Conditions
Brief summary
This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.
Interventions
DIAGNOSTIC_TESTTruGraf® Testing
5 mL collection PAXgene blood sample
Sponsors
The Methodist Hospital Research Institute
Transplant Genomics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody \>75%. * 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 are at least 30 days post-transplant.
Exclusion criteria
* Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant. * Recipients who do not meet criteria of high-immune risk. * Recipients of previous non-renal solid organ and/or islet cell transplantation. * Infection with HIV. * Infection with BK. * Patients that have nephrotic proteinuria (urine protein \>3 gm/day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Utility of TruGraf Results | 1 year | Percent of total number of TruGraf results that the PI identified as having clinical utility |
| Correlation of TruGraf Results | 1 year | Percent of total number of TruGraf results that the PI identified as being correlated to other clinical results obtained through the standard of care |
Countries
United States
Outcome results
None listed