Comparison of Captisol-Enabled™ Iohexol and Omnipaque™ in Patients With Impaired Renal Function Undergoing Coronary Angiography

Exclusion Criteria

• •1. eGFR \<15 mL/min/1.73 m2
• •2. Reduction in eGFR by approximately 25% that is considered to be acute per the Investigator's judgment
• •3. Body weight \>125 kg
• •4. Uncorrected clinically significant abnormalities of clinical laboratory assessments which, in the Investigator's opinion, will interfere with the study conduct, including but not limited to the following:
• •1. HbA1c \>10%
• •2. Blood glucose \>270 mg/dL
• •3. Hemoglobin \<8 g/dL
• •4. Albuminuria with UACR or UPCR \>4000 mg/g; or
• •5. Aspartate aminotransferase or alanine aminotransferase \>3 x upper limit of reference range
• •5. Positive test for severe acute respiratory syndrome coronavirus 2 RNA at Screening;
• •6. Positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C virus RNA at Screening
• •7. Uncontrolled hypertension, with systolic blood pressure (BP) \>180 mmHg or diastolic BP \>110 mmHg at Screening, based on the average of 3 BP measurements obtained from the patient's dominant arm
• •8. Hypotension, that is considered to be of recent occurrence per the Investigator's judgment, and required resuscitation with intravenous fluids
• •9. Non-cardiac acute illness or injuries that, in the opinion of the Investigator, could put the patient at risk or obscure the interpretation of the results of the study
• •10. Known allergy or sensitivity to iodinated contrast agents, Captisol, or any of the excipients in the study contrast agent that cannot be adequately managed with prophylactic treatment per the Investigator's judgment and Good Clinical Practice
• •11. Known allergy to heparin, history of heparin-induced thrombocytopenia, or history of heparin induced thrombocytopenia with thrombosis
• •12. Chronic disease(s) that, in the opinion of the Investigator, could interfere with (or for which the treatment might interfere with) the conduct of the study or interpretation of the study results or would place the patient at undue risk by participating in the study, including but not limited to the following:
• •1. NYHA class IV or decompensated heart failure; or
• •2. Cirrhosis of the liver
• •13. Inability to receive periprocedural intravenous volume expansion
• •14. Received contrast media within 10 days prior to the scheduled coronary angiography
• •15. Unable or not willing to come off non-steroidal anti-inflammatory drugs, including ibuprofen, for at least 24 hours before the scheduled procedure