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Kidney Transplant Rejection

Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Sponsored by Transplant Genomics, Inc.

About this trial

Last updated 4 years ago

Study ID

TGRP01-US001

Status

Terminated

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 4 years ago

What is this trial about?

This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

What are the participation requirements?

Yes

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 >90 days (+/- 2 weeks) post-transplant will be included in this study

No

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 nephropathy.

- Patients that have nephrotic proteinuria (urine protein >3 gm/day).

Locations

Location

Status