Assessment of Renal Function in Cirrhotic Patients | NCT01895114

Studies
Assessment of Renal Function in Cirrhotic Patients

NCT01895114

Sponsor

Baylor Research Institute

Status

Completed

Last Update Posted

Oct 6, 2025Actual

Enrollment

213Actual

Phase

Not provided

Conditions

Liver Failure
Renal Failure

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Apr 2021Actual

Completion Date

Jan 13, 2025Actual

First Submitted Date

Feb 11, 2013

First Submission Date that Met QC Criteria

Jul 5, 2013

First Posted Date

Jul 10, 2013Estimated

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

Oct 1, 2025

Last Update Posted Date

Oct 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to help determine whether cystatin C is a more sensitive laboratory measurement for renal function in cirrhotic patients.

Detailed Description

Serum cystatin C, creatinine clearance based calculations, and 125I-Iothalamate clearance (Glofil) will be obtained in 220 patients with cirrhosis. Utilizing this information, the correlation between cystatin C and 125I-Iothalamate clearance will be obtained. In addition, the current serum creatinine based calculations and true creatinine clearance will also be correlated with 125I-Iothalamate clearance. The results of this study should help to determine whether serum cystatin C is a more sensitive laboratory measurement of renal function in patients with cirrhosis.

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

213Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver.		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 18 undergoing evaluation for a liver transplant

Exclusion Criteria:

known allergy or sensitivity to 125I-Iothalamate

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

Patients from Baylor All Saints Medical Center and Baylor University Medical Center who have cirrhosis and a stable urine creatinine

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Fischbach, MD	Baylor All Saints	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor All Saint's Medical Center in Fort Worth		Fort Worth	Texas	76104	United States

Condition Browse Module

MeSH Terms

ID	Term
D017093	Liver Failure
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided