- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895114
Assessment of Renal Function in Cirrhotic Patients
October 1, 2025 updated by: Baylor Research Institute
Assessment of Renal Function in Cirrhotic Patients -A Comparison of Cystatin C and Creatinine Based Calculations to 125I-iothalamate
The purpose of this study is to help determine whether cystatin C is a more sensitive laboratory measurement for renal function in cirrhotic patients.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
213
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76104
- Baylor All Saint's Medical Center in Fort Worth
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients from Baylor All Saints Medical Center and Baylor University Medical Center who have cirrhosis and a stable urine creatinine
Description
Inclusion Criteria:
- over 18 undergoing evaluation for a liver transplant
Exclusion Criteria:
- known allergy or sensitivity to 125I-Iothalamate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bernard Fischbach, MD, Baylor All Saints
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
January 13, 2025
Study Registration Dates
First Submitted
February 11, 2013
First Submitted That Met QC Criteria
July 5, 2013
First Posted (Estimated)
July 10, 2013
Study Record Updates
Last Update Posted (Estimated)
October 6, 2025
Last Update Submitted That Met QC Criteria
October 1, 2025
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010-263
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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