Genetic Predisposition of Chronic Nephrotoxicity From Calcineurin Inhibitors in Liver Transplant Recipients, Potential Correlation With Urinary Biomarkers
Sponsor study identifier
observational
207
1 country
1
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
May 2012
Actual (reported)The purpose of this study is to determine the relationship between genomic variants of components of the renin-angiotensin system and the development of kidney problems due to Calcineurin-inhibitors post liver transplant.Also the investigator will evaluate the relationship between chronic renal failure post liver transplant and the risk of death. A sample of blood and urine wil be examined to see how the patient's genes are arranged in order to determine the difference in genes between people which may explain who will develop chronic renal failure after having received a liver transplant. The results may help us classify patients according to their risk and allow us to target their treatment to their individual need. In addition, it may ultimately lead to treatments that slows or prevents the development of chronic rejection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 2008
Actual (reported)March 6, 2009
Actual (reported)March 9, 2009
Actual (reported)May 2012
Actual (reported)To investigate, in liver transplant patients, the role of urinary biomarkers as indirect indices of chronic nephrotoxicity from CI and associate, where possible, urinary biomarkers to genomic variants of the angiotensin converting
Blood draw (20cc) and urine collection (80cc).
At time of enrollment
The study will also evaluate if specific demographic characteristics are associated with an increased risk of nephrotoxic damage from CI.
At time of enrollment
Organ transplant tolerance in subjects who are currently using immunosuppressant medications.
One additional blood draw - follow-up time point
Normal GFR (\>90ml/min/1.73m2). Stage I CKD
GFR between 30-59ml/min/1.73m2. Stage III CKD
GFR between 15-29ml/min/1.72m2. Stage IV CKD
This study will be conducted in liver transplant recipients. We are planning to collect data and genotyping in 650 liver transplant recipients. Patients who satisfy the following inclusion/exclusion criteria will be eligible for the study:
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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* Urine will be collected from all patients in the 3 groups and analyzed for biomarkers of interstitial fibrosis and proximal tubule injury. Specific biomarkers that will be tested are: urinary TGF-beta1, kidney injury molecule-1 and angiotensinogen. Urinary biomarkers will be normalized to creatinine and analyzed using an ELISA assay. * An additional 18mls of blood will be collected. This blood will be used to study organ transplant tolerance in subjects who are currently using immunosuppressant medications.
Lorenzo Gallon, M.D.
Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
207 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2009
First Posted
March 9, 2009
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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Primary Completion
October 2008
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
May 3, 2013
Record last verified: 2013-05
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