The purpose of this study is to determine if certain genes found in a kidney biopsy performed at one-year post transplant can predict which transplanted kidneys will have decreased kidney function within five years post-transplant.
Gene expression profiling is used to study the activity of genes. Each gene has an "on/off" switch that controls how they are expressed in a cell, as well as a "volume control" that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.
Study Type
OBSERVATIONAL
Enrollment
499
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Renal Function Decline
The primary endpoint for this study is defined as a progressive decline in renal function in participants with good function at 1 year. These "Progressors" are defined by all of the following criteria: 1. 1 year estimated GFR (eGFR) by MDRD equation of \>40 ml/min. 2. Decline in eGFR beyond 1 year during the time frame of this study (minimum 2.6 years after transplant and up to 5 years after transplant) with a slope of \<-6.1% (i.e. slope of decline of renal function is \>6.1%). 3. \>20% decline in eGFR from 1 year post-transplant to latest follow-up point. 4. At least one eGFR (MDRD) interval \< 60 ml/min.
Time frame: Baseline to 1 year
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