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

NCT00857844 | Completed

• 1 other identifier: STU8309 0773-018
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Transplanted Liver

Keywords

Chronic Nephrotoxicity; Kidney dysfunction post liver transplant; Urinary biomarkers of chronic nephrotoxicity from CI

Outcome Measures

Primary Outcomes (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

  Blood draw (20cc) and urine collection (80cc).

  At time of enrollment

Secondary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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:

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (37)

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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.

Study Officials

• Lorenzo Gallon, M.D.

  Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: May 1, 2012
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)