Genetic Predisposition-Chronic Nephrotoxicity From CI-Liver Transplant Recipients-Potential Correlation-Urinary Biomarkers
|ClinicalTrials.gov Identifier: NCT00857844|
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : May 3, 2013
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.
|Condition or disease|
|Complication of Transplanted Liver|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||207 participants|
|Official Title:||Genetic Predisposition of Chronic Nephrotoxicity From Calcineurin Inhibitors in Liver Transplant Recipients, Potential Correlation With Urinary Biomarkers|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||May 2012|
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
- 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 [ Time Frame: At time of enrollment ]Blood draw (20cc) and urine collection (80cc).
- The study will also evaluate if specific demographic characteristics are associated with an increased risk of nephrotoxic damage from CI. [ Time Frame: At time of enrollment ]Blood draw (20cc)
- Organ transplant tolerance in subjects who are currently using immunosuppressant medications. [ Time Frame: One additional blood draw - follow-up time point ]Blood draw (18cc).
Biospecimen Retention: Samples With DNA
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857844
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Lorenzo Gallon, M.D.||Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation|