Evaluation of Kidney Disease in Liver Transplant Recipients | NCT00585429

Studies
Evaluation of Kidney Disease in Liver Transplant Recipients

NCT00585429

Sponsor

University of Wisconsin, Madison

Status

Withdrawn

Last Update Posted

May 12, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Kidney Disease
Liver Transplantation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

key personnel left institution

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Jan 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided