Validation of Gene Expression Markers of Renal Allograft Functional Decline
This trial is active, not recruiting.
|Condition||kidney transplant recipients|
|Sponsor||National Institute of Allergy and Infectious Diseases (NIAID)|
|Start date||February 2013|
|End date||February 2018|
|Trial size||480 participants|
|Trial identifier||NCT01782586, DAIT GEN-04|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Renal Function Decline
time frame: Baseline to 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - Adult (≥18 years) conventional renal transplant recipient. - Patients who have given informed consent and are willing to comply with the protocol. Exclusion Criteria: - ABO incompatible kidney transplants. - Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric crossmatch >150). - Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, etc. Subjects who had previous extra renal transplants may be included in the study. - Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal biopsy. - An inability to have the 1-year renal biopsy performed within the acceptable protocol window (Months 11-14 [Days 301-420] post transplant).
|Official title||Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)|
|Principal investigator||MARK STEGALL, MD|
|Description||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.|
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