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Evaluation of Kidney Disease in Liver Transplant Recipients

This study has been withdrawn prior to enrollment.
(key personnel left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585429
First Posted: January 3, 2008
Last Update Posted: May 12, 2016
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates would be useful for monitoring of kidney damage. Particularly, the ability to predict irreversibility of such renal damage or progressive nature of renal disease in LT candidates would be of importance to determine the need for dual kidney-liver transplantation (KLT) versus LT alone. We will correlate kidney histology with cytokine/chemokine profile expression in the urine as a potentially useful noninvasive diagnostic tool.

Condition
Kidney Disease Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kidney Disease in Advanced Liver Disease Patients: A Study of Kidney Damage by a Urinary Cytokine/Chemokine Multiplex Assay

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • To determine the value of urinary levels of chemokines in the distinction between types of kidney disease in the setting of liver failure [ Time Frame: 1 year ]

Enrollment: 0
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
ESLD subjects on active liver transplant waiting list
2
Subjects post-liver transplant with good liver function
3
Subjects without liver disease undergoing kidney biopsy for diagnostic purposes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes.
Criteria

Inclusion Criteria:

  • Subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes.

Exclusion Criteria:

  • Contraindication to kidney biopsy
  • Inability to give informed consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00585429


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585429     History of Changes
Other Study ID Numbers: H-2006-0335
First Submitted: December 26, 2007
First Posted: January 3, 2008
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases