Molecular Biomarkers in Renal Transplantation Via TruGraf® Test

Launched by TRANSPLANT GENOMICS, INC. · May 20, 2020

Keywords

ClinConnect Summary

This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinine \<2.3 mg/dl, \<20% increase compare to the average of the previous 3 serum creatinine levels2.Kidney transplant patients who are:•more than 60 days post-transplant will be included in this study (Study A) •more than 2-yearspost-transplant but less than 5 years post-transplant (\>24 months but \< 60 months) will be included in this study (Study B) Scripps will enroll subjects who are post-tran...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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: \> 60 days post-transplant (Cohort A); \> 2-years post-transplant (Cohort B)
• Exclusion Criteria:
• • 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.
• • Patients that have nephritic proteinuria (urine protein \>3 gm/day).