Validation of Gene Expression Markers of Renal Allograft Functional Decline
Researchers would like to see if it is possible to predict which transplanted kidneys will do better long term based on the gene expression within a kidney biopsy one year after 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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)|
- Renal Function Decline [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: No ]
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 year estimated GFR (eGFR) by MDRD equation of >40 ml/min.
- 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%).
- >20% decline in eGFR from 1 year post-transplant to latest follow-up point.
- At least one eGFR (MDRD) interval < 60 ml/min.
Biospecimen Retention: Samples With DNA
biopsy & blood on 480 conventional kidney transplant participants
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782586
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|Contact: Michael Leonard 480-342-2908|
|Principal Investigator: Kunam Reddy, MD|
|Sub-Investigator: Raymond Heilman, MD|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Contact: Dana Kontras 904-953-8557|
|Principal Investigator: Thomas Gonwa, MD|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Iman Bajjoka 313-916-3709|
|Principal Investigator: Kim Dean, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Cindy Groettum 507-266-8725|
|Principal Investigator: Mark Stegall, MD|
|Principal Investigator:||MARK STEGALL, MD||Mayo Clinic, Rochester, MN|