Cardiac SurgeryNCT04654221
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
An observational study of Cardiac Surgery, run by Quark Pharmaceuticals at 6 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- mGFR by iohexol clearance
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Feb 2020to 26 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- Reduced renal function
- Diabetes with ongoing insulin treatment
- Albuminuria
- Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
Who cannot join
- Emergent surgeries, including aortic dissection, and major congenital heart defects
- Past cardiac surgery off CPB
- Have a known allergy to iohexol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Valley Clinical Trials
Covina, California, 91723
Duke University Medical Center
Durham, North Carolina, 27710
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
CB Flock Research
Mobile, Alabama, 36608
Valley Clinical Trials
Northridge, California, 91325
Advance Medical Research
St. Petersburg, Florida, 33713
About this study
Official title: 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
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- mGFR by iohexol clearance
- Keywords
- GFR, Acute Kidney Injury, AKI
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mGFR by iohexol clearanceDiagnostic test
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
| Study group | Role | What they receive |
|---|---|---|
| Male, BMI <= 24.9 | Male subjects with a BMI of less than or equal to 24.9 Receives: Diagnostic Test: mGFR by iohexol clearance | |
| Female, BMI <= 24.9 | Female subjects with a BMI of less than or equal to 24.9 Receives: Diagnostic Test: mGFR by iohexol clearance | |
| Male, BMI 25-29 | Male subjects with a BMI of 25 to 29 Receives: Diagnostic Test: mGFR by iohexol clearance | |
| Female, BMI 25-29 | Female subjects with a BMI of 25 to 29 Receives: Diagnostic Test: mGFR by iohexol clearance | |
| Male, BMI >29 | Male subjects with a BMI of greater than 29 Receives: Diagnostic Test: mGFR by iohexol clearance | |
| Female, BMI >29 | Female subjects with a BMI of greater than 29 Receives: Diagnostic Test: mGFR by iohexol clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 90 days post cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start21 Feb 2020
- Primary completion25 Feb 2021
- Study completion26 Mar 2021
Why it stopped: Study terminated early due to program discontinuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quark Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nitsan Halevy, MD, Study director, Quark Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654221
- Sponsor's protocol ID
- QRK509
- Status last verified
- Jul 2021
- First submitted
- 27 Nov 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04654221
- Acronym / sponsor ID
- QRK509
- Conditions
- Cardiac Surgery
- Keywords
- GFR, Acute Kidney Injury, AKI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated early due to program discontinuation.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Quark PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Male, BMI <= 24.9 | – | Diagnostic Test: mGFR by iohexol clearanceMale subjects with a BMI of less than or equal to 24.9 |
| Female, BMI <= 24.9 | – | Diagnostic Test: mGFR by iohexol clearanceFemale subjects with a BMI of less than or equal to 24.9 |
| Male, BMI 25-29 | – | Diagnostic Test: mGFR by iohexol clearanceMale subjects with a BMI of 25 to 29 |
| Female, BMI 25-29 | – | Diagnostic Test: mGFR by iohexol clearanceFemale subjects with a BMI of 25 to 29 |
| Male, BMI >29 | – | Diagnostic Test: mGFR by iohexol clearanceMale subjects with a BMI of greater than 29 |
| Female, BMI >29 | – | Diagnostic Test: mGFR by iohexol clearanceFemale subjects with a BMI of greater than 29 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
- Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
Key exclusion criteria (3 listed)
- Emergent surgeries, including aortic dissection, and major congenital heart defects
- Past cardiac surgery off CPB
- Have a known allergy to iohexol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mGFR by iohexol clearanceIohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance | Diagnostic test | Female, BMI 25-29, Female, BMI <= 24.9, Female, BMI >29, Male, BMI 25-29, Male, BMI <= 24.9, Male, BMI >29 |
Primary outcome
Correlation between eGFR and mGFR
Time frame: at 90 days post cardiac surgery
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.
Results and safety
The study was stopped early (reason given: Study terminated early due to program discontinuation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitsan Halevy, MD study director
Quark Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Quark Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated early due to program discontinuation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between eGFR and mGFR (time frame: at 90 days post cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.