Evaluation of Kidney Disease in Liver Transplant Recipients

NCT00585429 | Withdrawn

• 1 other identifier: H-2006-0335
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Disease; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• To determine the value of urinary levels of chemokines in the distinction between types of kidney disease in the setting of liver failure

  1 year

Study Arms (3)

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 Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to kidney biopsy
• Inability to give informed consent

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)