Kidney Transplant Rejection
Conditions
Keywords
Biomarkers, Subclinical Rejection
Brief summary
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and 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.
Detailed description
Several studies have validated TruGraf® in stable renal transplant patients to rule out subclinical acute rejection. These studies generally evaluated the diagnostic value of TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a serial and longitudinal fashion. Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.
Interventions
DIAGNOSTIC_TESTPatients monitored with TruGraf and TRAC testing
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.
Sponsors
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
* Written informed consent and HIPAA authorization; * At least 18 years of age; * Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant; * At least 3-months post-transplant; * Stable serum creatinine (per Principal Investigator); * Treated with any immunosuppressive regimen, and; * Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and
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 be pregnant; * Known to be infected with HIV; * Known to have Active BK nephropathy; * Known to have nephrotic proteinuria (Per Principal Investigator); * Participation in other biomarker studies testing clinical utility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min. | Baseline to month 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First occurrence of clinically treated acute rejection | Baseline to month 24 | — |
| Proteinuria | Baseline to month 24 | defined by a spot urine protein-creatinine ratio \> 0.5 |
| TruGraf results | Baseline to month 24 | The proportion of TruGraf not-TX results |
| TRAC results | Baseline to month 24 | The proportion of TRAC results \> 0.69 |
| Clinical Utility of TruGraf and TRAC in clinical decision making | Baseline to month 24 | Percent of total number of TruGraf results that the PI identified as having clinical utility |
| Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA) | Baseline to month 24 | Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA) |
| First occurrence of biopsy proven acute rejection (on a for cause biopsy) | Baseline to month 24 | — |
| Graft survival | Baseline to month 24 | calculated from the date of kidney transplantation until data of graft loss |
| Proportion of subjects with death-censored graft loss | Baseline to month 24 | defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored |
| Percent subject death period | Baseline to month 24 | Subject death from any cause at any time |
| Subject survival | Baseline to month 24 | calculated from date of kidney transplantation until date of patient death |
| Estimated GFR | Baseline to month 24 | calculated using the MDRD 4-variable equation |
| Proportion of subjects with graft loss | Baseline to month 24 | defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period |
Countries
United States
Contacts
Primary ContactIsioma Agboli, MD
Outcome results
None listed