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.
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).
Study Type
OBSERVATIONAL
Enrollment
307
Mayo Clinic, Division of Nephrology
Phoenix, Arizona, United States
The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation,
La Jolla, California, United States
Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation
Chicago, Illinois, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Medical University of South Carolina, Division of Transplant
Charleston, South Carolina, United States
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
Time frame: 12 and 24 months
Incidence of Death
Time frame: Baseline to month 24
Incidence of Graft Loss
Time frame: Baseline to month 24
Incidence of Opportunistic infections
Time frame: Baseline to month 24
Incidence of BKV, CMV, and EBV Infection
Time frame: Baseline to month 24
Incidence of Treated Urinary Tract Infection
Time frame: Baseline to month 24
Incidence of Malignancy
Time frame: Baseline to month 24
Changes that Occur in Blood, Urine, and Kidney Tissue Gene Expression Signature
Time frame: Month 1 to month 24
Changes in Plasma Protein Expression Profile
Time frame: Month 1 to month 24
Changes in Urine Protein Expression Profile
Time frame: Month 1 to month 24
Changes in Blood MicroRNA Expression Profile
Time frame: Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Response to Therapy for AR
Time frame: Month 1 to month 24
Evolution of Gene and Protein Expression Profiles During Progression or Regression of CAN/IFTA on Protocol Biopsies
Time frame: Month 1 to month 24
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