Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

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

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

Study Overview

• Status: Terminated
• Conditions: Cardiac Surgery
• Intervention / Treatment: Diagnostic test: mGFR by iohexol clearance

Detailed Description

This is an open label, single-visit study to evaluate the relationship between mGFR and eGFR based either on serum creatinine (eGFRcreat) or cystatin C (eGFRcys) approximately 90 days following cardiac surgery. No investigational study drug will be administered.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • CB Flock Research
  • California
    • Covina, California, United States, 91723
      • Valley Clinical Trials
    • Northridge, California, United States, 91325
      • Valley Clinical Trials
  • Florida
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates, Inc.
    • Saint Petersburg, Florida, United States, 33713
      • Advance Medical Research
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Key Inclusion Criteria:

• Male or female, age ≥ 45 years old

• At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:

  1. Reduced renal function
  2. Diabetes with ongoing insulin treatment
  3. Albuminuria
• Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

• Emergent surgeries, including aortic dissection, and major congenital heart defects
• Past cardiac surgery off CPB
• Have a known allergy to iohexol

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male, BMI <= 24.9; Male subjects with a BMI of less than or equal to 24.9	Diagnostic test: mGFR by iohexol clearance; Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Female, BMI <= 24.9; Female subjects with a BMI of less than or equal to 24.9	Diagnostic test: mGFR by iohexol clearance; Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Male, BMI 25-29; Male subjects with a BMI of 25 to 29	Diagnostic test: mGFR by iohexol clearance; Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Female, BMI 25-29; Female subjects with a BMI of 25 to 29	Diagnostic test: mGFR by iohexol clearance; Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Male, BMI >29; Male subjects with a BMI of greater than 29	Diagnostic test: mGFR by iohexol clearance; Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Female, BMI >29; Female subjects with a BMI of greater than 29	Diagnostic test: mGFR by iohexol clearance; Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Quark Pharmaceuticals
• Investigators: Study Director: Nitsan Halevy, MD, Quark Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; AKI; GFR
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: QRK509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No