Validation of Gene Expression Markers of Renal Allograft Functional Decline
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|ClinicalTrials.gov Identifier: NCT01782586|
Recruitment Status : Active, not recruiting
First Posted : February 4, 2013
Last Update Posted : May 7, 2018
|Condition or disease|
|Kidney Transplant Recipients|
|Study Type :||Observational|
|Actual Enrollment :||480 participants|
|Official Title:||Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
- Renal Function Decline [ Time Frame: Baseline to 1 year ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782586
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||MARK STEGALL, MD||Mayo Clinic, Rochester, MN|