NCT01895114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
Last Updated

October 6, 2025

Status Verified

July 1, 2015

Enrollment Period

10.3 years

First QC Date

February 11, 2013

Last Update Submit

October 1, 2025

Conditions

Liver FailureRenal Failure

Keywords

Renal functioncirrhotic patientstransplant evaluation

Outcome Measures

Primary Outcomes (1)

  • Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver.

    24 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • over 18 undergoing evaluation for a liver transplant

You may not qualify if:

  • known allergy or sensitivity to 125I-Iothalamate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor All Saint's Medical Center in Fort Worth

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Liver FailureRenal Insufficiency

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Bernard Fischbach, MD

    Baylor All Saints

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2013

First Posted

July 10, 2013

Study Start

December 1, 2010

Primary Completion

April 1, 2021

Study Completion

January 13, 2025

Last Updated

October 6, 2025

Record last verified: 2015-07

Locations

US(1)