Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study terminated early due to program discontinuation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male, BMI <= 24.9 | Male subjects with a BMI of less than or equal to 24.9 |
| |
| Female, BMI <= 24.9 | Female subjects with a BMI of less than or equal to 24.9 |
| |
| Male, BMI 25-29 | Male subjects with a BMI of 25 to 29 |
| |
| Female, BMI 25-29 | Female subjects with a BMI of 25 to 29 |
| |
| Male, BMI >29 | Male subjects with a BMI of greater than 29 |
| |
| Female, BMI >29 | Female subjects with a BMI of greater than 29 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mGFR by iohexol clearance | Diagnostic Test | Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance |
|
| 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 |
Not provided
Not provided
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:
Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
Key Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nitsan Halevy, MD | Quark Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CB Flock Research | Mobile | Alabama | 36608 | United States | ||
| Valley Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |