Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Individual Recipients of living or deceased donor kidney transplant
2. Age: ≥ 18 ≤ 80
3. The subject must be able to comprehend and sign an approved informed consent form
Exclusion Criteria:
1. Recipients of multiple organ transplant, except kidney-pancreas multiple transplant
2. Subjects who are currently participating in a therapeutic clinical trial for transplant rejection
3. HIV or Hepatitis C positive patients
4. Persons who are known to be pregnant
Primary outcome measure(s)
Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) — baseline early acute rejection occurring within first 6 months, including borderline ACR
Acute Cellular Rejection (ACR): test to identify the risk of clinical and sub-clinical ACR — 6 months clinical or subclinical acute rejection 3 months post transplant including borderline ACR, acute cell-mediated rejection as confirmed by histologic evidence on biopsy
Fibrosis: test to predict the risk of developing fibrosis of the allograft and allograft loss — 24 months clinical or subclinical acute rejection due to fibrosis 12 months post transplant as confirmed by histologic evidence on biopsy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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