Evaluation of Kidney Disease in Liver Transplant Recipients

This study has been withdrawn prior to enrollment.
(key personnel left institution)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585429
First received: December 26, 2007
Last updated: January 29, 2009
Last verified: January 2009
  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

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585429

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

No publications provided

Responsible Party: Milagros Samaneigo, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585429     History of Changes
Other Study ID Numbers: 2006-0335
Study First Received: December 26, 2007
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 09, 2014