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Trial record 4 of 4 for:    12081583 [PUBMED-IDS]

Genetic Predisposition-Chronic Nephrotoxicity From CI-Liver Transplant Recipients-Potential Correlation-Urinary Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857844
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : May 3, 2013
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Lorenzo Gallon, Northwestern University

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Group 1
Normal GFR (>90ml/min/1.73m2). Stage I CKD
Group 2
GFR between 30-59ml/min/1.73m2. Stage III CKD
Group 3
GFR between 15-29ml/min/1.72m2. Stage IV CKD

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

Inclusion Criteria:

  • Informed consent
  • Males and females > 18 years old
  • Liver transplant recipients who have received a liver transplant at least 6 months ago
  • Liver transplant recipients receiving a maintenance immunosuppression.

Exclusion Criteria:

  • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Pre-existing known kidney disease before liver transplantation
  • Multi-organ transplant

Information from the National Library of Medicine

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 identifier (NCT number): NCT00857844

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Northwestern Memorial Hospital
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Principal Investigator: Lorenzo Gallon, M.D. Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

Amer H, Lieske J, Grande J, Stegall M, Larson T. Urinary TGF-beta1 predicts progressive renal allograft fibrosis on one year protocol biopsies. Abstract, ASN, 2006. San Diego
Iwazu Y, Muto S, Hirahara I, Fujisawa G, Miyata Y, Kusano E. Urinary matrix metalloproteinase is a useful marker for the development of Deoxycorticosterone Acetate/salt-induced tubulointerstitial fibrosis. Abstract, ASN, 2006. San Diego

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Responsible Party: Lorenzo Gallon, Associate Professor, Northwestern University Identifier: NCT00857844     History of Changes
Other Study ID Numbers: STU8309 0773-018
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Lorenzo Gallon, Northwestern University:
Chronic Nephrotoxicity
Kidney dysfunction post liver transplant
Urinary biomarkers of chronic nephrotoxicity from CI

Additional relevant MeSH terms:
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Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action