Evaluation of Kidney Disease in Liver Transplant Recipients - Full Text View

Evaluation of Kidney Disease in Liver Transplant Recipients

This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, June 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585429

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

MedlinePlus related topics:

Liver Transplantation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

ESLD subjects on active liver transplant waiting list

Subjects post-liver transplant with good liver function

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

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

Contacts


Contact: Aimee Sundberg, PharmD	608-263-2565	sundberg@surgery.wisc.edu

Locations


United States, Wisconsin
	University of Wisconsin	Recruiting
	Madison, Wisconsin, United States, 53792
	Principal Investigator: Milagros Samaneigo, MD

Sponsors and Collaborators

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( Milagros Samaneigo, MD )
Study ID Numbers:	2006-0335
First Received:	December 26, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00585429
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urologic Diseases

Kidney Diseases

ClinicalTrials.gov processed this record on October 28, 2008