Study terminated early due to program discontinuation.
Evaluation of eGFR, Determined by Cystatin C and Creatinine, and mGFR, Measured by Iohexol Clearance, in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Sponsor study identifier
observational
16
1 country
6
Study Start
February 21, 2020
Actual (reported)Primary Completion
February 25, 2021
Actual (reported)Study Completion
March 26, 2021
Actual (reported)To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute kidney injury (AKI) approximately 90 days following cardiac surgery
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 26, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2020
Actual (reported)November 27, 2020
Actual (reported)December 4, 2020
Actual (reported)February 25, 2021
Actual (reported)March 26, 2021
Actual (reported)Correlation between eGFR and mGFR
The primary measure will be the comparison of the P(30) and P(10) between eGFR based on serum cystatin C (eGFRcys) and eGFR based on serum creatinine (eGFRcreat). P(30) and P(10) are defined as the percentage of subjects whose eGFR is within 30% (10%) of the iohexol-based mGFR.
at 90 days post cardiac surgery
Male subjects with a BMI of less than or equal to 24.9
Female subjects with a BMI of less than or equal to 24.9
Male subjects with a BMI of 25 to 29
Female subjects with a BMI of 25 to 29
Male subjects with a BMI of greater than 29
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects who have undergone non-emergent cardiac surgery and were at high risk of developing AKI, who meet all of the Inclusion and none of the Exclusion criteria, will be eligible.
CB Flock Research
Mobile, Alabama, 36608, United States
Valley Clinical Trials
Covina, California, 91723, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Advance Medical Research
St. Petersburg, Florida, 33713, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Nitsan Halevy, MD
Quark Pharmaceuticals
16 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2020
First Posted
December 4, 2020
Study Start
February 21, 2020
Actual (reported)Female subjects with a BMI of greater than 29
Contact the study team to confirm eligibility.
Primary Completion
February 25, 2021
Actual (reported)Study Completion
March 26, 2021
Actual (reported)Last Updated
July 16, 2021
Record last verified: 2021-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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