Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients

Study Overview
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Brief Summary
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There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

Detailed Description
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Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. One field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's cellular traits. Gene expression is when information found in one's DNA is translated into RNA and eventually proteins. These components are present in each of the body's cells. In this study, researchers are trying to learn if certain changes in the RNA and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. The blood and urine tests will look for patterns in one's DNA (called genetic markers). This study will follow subjects for 2 years after transplant. There will be a total of 12 study visits with additional study visits if rejection occurs. The study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).

Official Title
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Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics

Conditions
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Kidney Transplant, Kidney Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation Subject and/or parent guardian must be able to understand and provide informed consent Female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry. Exclusion Criteria: Need for combined organ transplantation with an extra-renal organ and/or islet Recipient of previous non-renal solid organ and/or islet cell transplantation Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) Inability or unwillingness of a participant to give written informed consent or comply with study protocol Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Biopsy Proven Acute Rejection (AR)-Clinical and Sub-Clinical), Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (CAN/IFTA), and Normal Renal Biopsy with Stable, Good Kidney Function |  | 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Death |  | Baseline to month 24 | 
| Incidence of Graft Loss |  | Baseline to month 24 | 
| Incidence of Opportunistic infections |  | Baseline to month 24 | 
| Incidence of BKV, CMV, and EBV Infection |  | Baseline to month 24 | 
| Incidence of Treated Urinary Tract Infection |  | Baseline to month 24 | 
| Incidence of Malignancy |  | Baseline to month 24 | 
| Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature |  | Month 1 to month 24 | 
| Changes in Plasma Protein Expression Profile |  | Month 1 to month 24 | 
| Changes in Urine Protein Expression Profile |  | Month 1 to month 24 | 
| Changes in Blood MicroRNA Expression Profile |  | Month 1 to month 24 | 
| Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR |  | Month 1 to month 24 | 
| Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies |  | Month 1 to month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarkers, proteogenomic profiling, acute rejection, chronic allograft nephropathy/interstitial fibrosis and tubular atrophy