Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This is a single-center, prospective, non-randomized, observational study to evaluate specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely monitored over one year after enrollment.

Detailed Description
-----------------
OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue.

Official Title
-----------------
Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients

Conditions
-----------------
Delayed Graft Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment as study participants: Male and female recipients of all races, ≥18 years of age. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation. Subject and/or guardian must be able to provide informed consent. Subject and/or guardian must be able to comply with the study protocol. 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. Inability or unwillingness of a participant and/or guardian to provide informed consent -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1<br>A. OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue. B. STUDY DESIGN: Enroll 20 subjects who are post-transplant and are undergoing kidney transplant biopsies at the UC Davis transplant center. Ten subjects will be enrolled who are receiving surveillance protocol biopsies and 10 subjects. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy prove acute rejection | Incidence of acute rejection at the time of any kidney biopsy | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Expression Profiling | Blood and tissue collection from each subject at the time of each for cause or protocol kidney biopsy | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Biopsy, elevated serum creatinine, proteinuria